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Join to apply for the Medical Science Liaison - Northeast, (NY, ME, VT, NH and Western MA) role at SUN PHARMA

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Join to apply for the Medical Science Liaison - Northeast, (NY, ME, VT, NH and Western MA) role at SUN PHARMA

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Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary

The Medical Science Liaison (MSL) will represent Sun Pharmaceutical (SUN).

The MSL will primarily identify and engage with a targeted group of national and regional thought leaders/healthcare professionals (HCPs) as well as payers and managed care accounts, providing the consistent delivery of educational and compliant scientific information in support of Dermatology products. The MSLs will engage with HCPs, NPs, & PAs who are in clinical practice caring for their patients. They will be trained to respond to complex inquiries in a scientific, fair-balanced, compliant manner serving as a critical field medical resource to these HCPs and also, internal SUN sales and managed markets constituents.

Responsibilities

• Interact with healthcare providers and thought leaders to communicate and advance the scientific platform as aligned with SUN’s corporate goals and objectives.
• Communicate complex scientific information and research concepts to HCPs
• Provide clinical and economic value information to payers and formulary decision makers
• Identify and train members of SUN’s speakers’ bureau and ensure they are updated on new data
• Respond to requests for investigator sponsored research (ISS) proposals and transit them into Sun and present the research to Sun for review. They will become the point of contact with the HCPs if ISS research is accepted and funded by Sun
• Support SUN sponsored research
• Provide feedback based on field interactions with healthcare providers and Thought Leaders to SUN stakeholders
• Respond to scientific inquires consistent with the MSL compliance standards,
• Foster scientific relationships between SUN and Fellows in training
• Lead and/or participate on committees or project teams that support MSL strategies and tactics as delegated by MSL leadership
• Seek out opportunities to support the MSL value proposition, achieve results and set an example for others to follow by consistently demonstrating SUN values and leadership attributes
• Must have the ability to gain customer feedback, uncover business opportunities for SUN and pair customer's unmet needs with available internal resources.
• Must be a strong team player who can effectively interface with SUN clinical and commercial personnel, as well as aide in training of SUN staff.
• Demonstrate tact and professionalism when communicating and interacting with others
• Comply with all applicable SUN Health Care Compliance SOPs and US regulations
  
  

• Doctorate / Terminal degree required (eg, PharmD, MD, DO, DNP or PhD)
• Dermatology background strongly preferred
• 1-3 years of clinical, research and/or field medical experience preferred
• Thorough grasp of the pharmaceutical industry, FDA requirements and PhRMA code
• Strong interpersonal, organizational, team, written and verbal communication skills
• Strong presentation and education skills; ability to communicate clinical and non-clinical technical information effectively
• Demonstrated project management ability
• Travel up to 60-70%
• Proficiency in Microsoft Office suite applications
• Valid driver’s license
  
  

Kenvue Cape Town, Western Cape, South Africa

Join to apply for the Senior Regulatory Affairs Specialist role at Kenvue

Kenvue Cape Town, Western Cape, South Africa

Join to apply for the Senior Regulatory Affairs Specialist role at Kenvue

What We Do

Kenvue Is Currently Recruiting For A:

Senior Regulatory Affairs Specialist

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role Reports To:

Head of Regulatory Operations, Scientific Affairs & External Engagement, SA-SSA

Location:

Europe/Middle East/Africa, South Africa, Gauteng, Johannesburg

Work Location:

Hybrid

What You Will Do

Kenvue is currently recruiting for:

Senior Regulatory Affairs Specialist

This position reports into Senior Manager Regulatory Affairs and is based at Cape Town, South Africa

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to: Senior Manager Regulatory Affairs

Location: Cape Town, South Africa

What You Will Do

The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.

• Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan.
• Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
• Maintains compliance for all products with local regulations and quality system requirements.
  
  

• Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams.
• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
• Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.
  
  

• Maintains awareness of current regulations and anticipates implications and opportunities because of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally.
• Ensures that all products comply with local regulatory and quality system requirements.
• Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.
• Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support.
• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
• Ensures that the enterprise Regulatory systems are accurate and fully maintained.
• Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
• Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• Supports internal and external audits and inspections in collaboration with quality function.
  
  

• Relevant Bachelor's Degree (B. Pharm) or higher (M. Pharm, MSc. Pharm etc.)
• 6+yrs related regulatory experience.
• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Leadership and coaching skills with proven experience of people development
• Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility
• Strong personal and people leadership, able to coach and develop emerging talent
• Broad knowledge of consumer healthcare environment and product development
• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• Strong organizational and time management skills with an ability to work under pressure.
• Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic,
• Results-driven environment.
• Able to work effectively in a multi-cultural, highly matrixed organization
• Proficiency in English
  
  

• Be registered member of the South African Pharmacy Council
• Be designated Practising Pharmacist by the Health Authorities
• Knowledge of cGMP, ISO 13485, South African and Sub-Sahara Africa legislation for pharmaceutical, Cosmetics, Foodstuffs and Medical Devices
• Knowledge of production, Quality Assurance, Quality Control, validation.
• At least 2 years of experience as QP deputy
  
  

• Competitive Package
• Learning & Development Opportunities
• Kenvuer Impact Networks
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal
• Industries Personal Care Product Manufacturing

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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior Biostatistician:

Roles & Responsibilities

• Providesinput into statistical sections and overall consistency of clinical study protocols.
• Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client.
• Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
• Works with programming team to provide inputfor analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets.
• Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial.
• Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
• Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.
• Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Works with the project management group to ensure timelines are appropriate given the scope of the project.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
• Demonstrates strong understanding of ICH guidelines, as applicable to statistics.
• Practices good internal and external customer service.

Requirements

• Master of Science (in statistics of equivalent) with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experience.
• Strong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph).
• Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputs.
• Excellent mathematical and problem-solving skills.
• Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data.
• Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats).
• Strong familiarity with a variety of clinical data and databases (including EDC systems)
• Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
• At least three (3) years of experience in pharmaceutical industry.
• Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time.
• Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
• Good interpersonal, oral, and written communication skills.
• Self-motivated, hardworking, dependable, and positive team-oriented personality.
• Ability to communicate effectively and provide clear directions to Statistical Programmers

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior Biostatistician:

Roles & Responsibilities

• Providesinput into statistical sections and overall consistency of clinical study protocols.
• Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client.
• Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
• Works with programming team to provide inputfor analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets.
• Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial.
• Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
• Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.
• Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Works with the project management group to ensure timelines are appropriate given the scope of the project.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
• Demonstrates strong understanding of ICH guidelines, as applicable to statistics.
• Practices good internal and external customer service.

Requirements

• Master of Science (in statistics of equivalent) with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experience.
• Strong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph).
• Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputs.
• Excellent mathematical and problem-solving skills.
• Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data.
• Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats).
• Strong familiarity with a variety of clinical data and databases (including EDC systems)
• Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
• At least three (3) years of experience in pharmaceutical industry.
• Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time.
• Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
• Good interpersonal, oral, and written communication skills.
• Self-motivated, hardworking, dependable, and positive team-oriented personality.
• Ability to communicate effectively and provide clear directions to Statistical Programmers

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

PATH current employees - please log in and apply

PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges.

PATH is deeply committed to implementing our strategic vision focused on strengthening people-centered primary health care (PHC) to help countries and health systems adapt and respond to a changing world, move toward Universal Health Coverage (UHC), and achieve the health-related Sustainable Development Goals. The PHC program focuses on advancing integrated people-centered care and systems through a life course approach, and includes capabilities in health systems, integrated maternal and child health and development, nutrition, sexual and reproductive health (SRH), HIV, viral hepatitis, and other STIs, tuberculosis, noncommunicable diseases, and more.

The Future Injectable Market Steward (FIMS) project is a multi-country effort to facilitate the sustainable availability of injectable contraceptive options, including self-injection of DMPA-SC, as part of an expanded range of family planning methods delivered through informed choice programming. DMPA-SC offers a safe and effective injectable contraceptive that clients can, once trained, inject themselves if they choose. At the core of the FIMS mission is the belief that when women and adolescents have access to a variety of contraceptives, including those they can manage themselves, they are more likely to find and consistently use a method that meets their needs and ultimately realize their reproductive intentions.

The Technical Director / Senior Commercialization Officer will be responsible for gathering, analyzing and interpreting market data to inform global strategic decisions for DMPA-SC and the broader injectables market. This individual will also be a key point of contact for private sector stakeholders, including suppliers, distributors, social marketing non-governmental organizations (NGO), and other private sector partners.

Specific roles and responsibilities :

• Lead the development of an annual DMPA-SC Market Strategy that serves as a global roadmap towards a healthy DMPA-SC market and provides data-informed recommendations for donors, governments and manufacturers to align demand with available supply, including generic DMPA-SC products.
• Apply a total market approach to DMPA-SC introduction and scale, including engaging proactively with private sector partners, including suppliers and delivery partners around financing / pricing, application of available data to guide new product introduction, and general recommendations based on market research.
• Responsible for managing external relationships with key stakeholders, including UNFPA, product manufacturers, WHO, and Consensus Planning group, ensuring effective collaboration and alignment.
• Collaborate with internal and external partners, including donors, advisory bodies, manufacturers, commercial distributors, and NGOs, develop and provide analytics to inform discussions and to identify and resolve key market barriers.
• Facilitate and guide the regional resource teams, who provide technical assistance to country teams related to supply chain strengthening, monitoring and evaluation, sustainable financing, and evidence-informed advocacy.
• Engage with ministries of health, regional bodies, donors, and other partners, serving as a technical / scientific expert and external representative for global advocacy and policy efforts, including through webinars and presentations at international conferences and other fora.

Required expertise :

• Master’s degree in business administration, marketing, life sciences, or a related field.
• Advanced commercialization expertise, including 10+ years of comprehensive experience in commercial market access work for a pharmaceutical, life sciences, or commercial wholesaler, or distribution company, preferably related to women’s health products.
• Experience commercializing health products from market entry to saturation in low-resource settings, including experience with regulatory processes and compliance.
• Experience ideating and implementing strategies to ensure supply availability of health commodities within low and middle-income country (LMIC) supply chains.
• Experience utilizing complicated or nuanced data for strategic decision-making. Familiarity with data systems and data availability in low-resource settings preferred.
• Proven experience in ideating and developing data-driven solutions that address the needs and challenges of private sector distributors and partners in delivering new products and services.
• Deep expertise with rigorous quantitative analysis and modeling is required. Analyses led by the Technical Commercialization Director may include : rapid demand forecasting, product uptake and quantification analyses, and supply management scenario planning analyses.
• Proven ability to lead cross-cultural teams, demonstrate cultural sensitivity, and manage people with a commitment to building a shared vision and positive team culture across multiple country sites. At least three years of management or supervisory experience is required, along with above-average emotional intelligence and the ability to give and receive constructive feedback
• Experience building and managing relationships at global, regional, and national levels, including with donors, multilateral organizations, implementing partners, governments, local organizations, academic institutions, and the private sector.

Technical Director • South Africa, Johannesburg Project Office

Date: Feb 20, 2025

Location: FS-Sun

Company: Sun Pharmaceutical Industries, Inc (USA)

Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary:

The Medical Science Liaison (MSL) will represent Sun Pharmaceutical (SUN). The MSL will primarily identify and engage with a targeted group of national and regional thought leaders/healthcare professionals (HCPs) as well as payers and managed care accounts, providing the consistent delivery of educational and compliant scientific information in support of Dermatology products. The MSLs will engage with HCPs, NPs, & PAs who are in clinical practice caring for their patients. They will be trained to respond to complex inquiries in a scientific, fair-balanced, compliant manner serving as a critical field medical resource to these HCPs and also, internal SUN sales and managed markets constituents.

Responsibilities:

• Interact with healthcare providers and thought leaders to communicate and advance the scientific platform as aligned with SUN’s corporate goals and objectives.
• Communicate complex scientific information and research concepts to HCPs.
• Provide clinical and economic value information to payers and formulary decision makers.
• Identify and train members of SUN’s speakers’ bureau and ensure they are updated on new data.
• Respond to requests for investigator sponsored research (ISS) proposals and transit them into Sun and present the research to Sun for review. They will become the point of contact with the HCPs if ISS research is accepted and funded by Sun.
• Support SUN sponsored research.
• Provide feedback based on field interactions with healthcare providers and Thought Leaders to SUN stakeholders.
• Respond to scientific inquiries consistent with the MSL compliance standards.
• Foster scientific relationships between SUN and Fellows in training.
• Lead and/or participate on committees or project teams that support MSL strategies and tactics as delegated by MSL leadership.
• Seek out opportunities to support the MSL value proposition, achieve results and set an example for others to follow by consistently demonstrating SUN values and leadership attributes.
• Must have the ability to gain customer feedback, uncover business opportunities for SUN and pair customer's unmet needs with available internal resources.
• Must be a strong team player who can effectively interface with SUN clinical and commercial personnel, as well as aide in training of SUN staff.
• Demonstrate tact and professionalism when communicating and interacting with others.
• Comply with all applicable SUN Health Care Compliance SOPs and US regulations.

Qualifications:

• Doctorate / Terminal degree required (eg, PharmD, MD, DO, DNP or PhD).
• Dermatology background strongly preferred.
• 1-3 years of clinical, research and/or field medical experience preferred.
• Thorough grasp of the pharmaceutical industry, FDA requirements and PhRMA code.
• Strong interpersonal, organizational, team, written and verbal communication skills.
• Strong presentation and education skills; ability to communicate clinical and non-clinical technical information effectively.
• Demonstrated project management ability.
• Travel up to 60-70%.
• Proficiency in Microsoft Office suite applications.
• Valid driver’s license.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior Biostatistician:

Roles & Responsibilities

• Providesinput into statistical sections and overall consistency of clinical study protocols.
• Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client.
• Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
• Works with programming team to provide inputfor analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets.
• Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial.
• Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
• Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.
• Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Works with the project management group to ensure timelines are appropriate given the scope of the project.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
• Demonstrates strong understanding of ICH guidelines, as applicable to statistics.
• Practices good internal and external customer service.

Requirements

• Master of Science (in statistics of equivalent) with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experience.
• Strong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph).
• Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputs.
• Excellent mathematical and problem-solving skills.
• Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data.
• Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats).
• Strong familiarity with a variety of clinical data and databases (including EDC systems)
• Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
• At least three (3) years of experience in pharmaceutical industry.
• Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time.
• Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
• Good interpersonal, oral, and written communication skills.
• Self-motivated, hardworking, dependable, and positive team-oriented personality.
• Ability to communicate effectively and provide clear directions to Statistical Programmers

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior Biostatistician:

Roles & Responsibilities

• Providesinput into statistical sections and overall consistency of clinical study protocols.
• Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client.
• Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
• Works with programming team to provide inputfor analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets.
• Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial.
• Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
• Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.
• Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Works with the project management group to ensure timelines are appropriate given the scope of the project.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
• Demonstrates strong understanding of ICH guidelines, as applicable to statistics.
• Practices good internal and external customer service.

Requirements

• Master of Science (in statistics of equivalent) with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experience.
• Strong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph).
• Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputs.
• Excellent mathematical and problem-solving skills.
• Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data.
• Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats).
• Strong familiarity with a variety of clinical data and databases (including EDC systems)
• Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
• At least three (3) years of experience in pharmaceutical industry.
• Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time.
• Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
• Good interpersonal, oral, and written communication skills.
• Self-motivated, hardworking, dependable, and positive team-oriented personality.
• Ability to communicate effectively and provide clear directions to Statistical Programmers

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Join to apply for the Medical Science Liaison - Oncology -Central role at SUN PHARMA

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Join to apply for the Medical Science Liaison - Oncology -Central role at SUN PHARMA

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Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary

The MSL will primarily identify and engage with a targeted group of national and regional thought leaders/healthcare professionals (HCPs) as well as payers and managed care accounts, providing the consistent delivery of educational and compliant scientific information in support of Oncology products. The MSLs will engage with HCPs, NPs, & PAs who are in clinical practice caring for their patients. They will be trained to respond to complex inquiries in a scientific, fair-balanced, compliant manner serving as a critical field medical resource to these HCPs and also, internal SUN sales and managed markets constituents.

Responsibilities

• Interact with healthcare providers and thought leaders to communicate and advance the scientific platform as aligned with SUN’s corporate goals and objectives.
• Communicate complex scientific information and research concepts to HCPs
• Provide clinical and economic value information to payers and formulary decision makers
• Identify and train members of SUN’s speakers’ bureau and ensure they are updated on new data
• Respond to requests for investigator sponsored research (ISS) proposals and transit them into Sun and present the research to Sun for review. They will become the point of contact with the HCPs if ISS research is accepted and funded by Sun
• Support SUN sponsored research
• Provide feedback based on field interactions with healthcare providers and Thought Leaders to SUN stakeholders
• Respond to scientific inquires consistent with the MSL compliance standards,
• Foster scientific relationships between SUN and Fellows in training
• Lead and/or participate on committees or project teams that support MSL strategies and tactics as delegated by MSL leadership
• Seek out opportunities to support the MSL value proposition, achieve results and set an example for others to follow by consistently demonstrating SUN values and leadership attributes
• Must have the ability to gain customer feedback, uncover business opportunities for SUN and pair customer's unmet needs with available internal resources.
• Must be a strong team player who can effectively interface with SUN clinical and commercial personnel, as well as aide in training of SUN staff.
• Demonstrate tact and professionalism when communicating and interacting with others
• Comply with all applicable SUN Health Care Compliance SOPs and US regulations
  
  

• Doctorate / Terminal degree required (eg, PharmD, MD, DO, DNP or PhD)
• Oncology background strongly preferred
• 1-3 years of clinical, research and/or field medical experience preferred
• Thorough grasp of the pharmaceutical industry, FDA requirements and PhRMA code
• Strong interpersonal, organizational, team, written and verbal communication skills
• Strong presentation and education skills; ability to communicate clinical and non-clinical technical information effectively
• Demonstrated project management ability
• Travel up to 60-70%
• Proficiency in Microsoft Office suite applications
• Valid driver’s license