Job Description
Job Title: Senior Project Biostatistics Lead- Vaccines Location: Waltham, MA
About the Job Lead Biostatistician for medium complexity vaccine project (one or several indications) in clinical development and/or post-marketing stage. The incumbent is accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities: Act as a Senior Biostatistics Expert at vaccine project level:
- Develop with other clinical/medical and global project team members the end-to-end clinical development plan for the vaccine;
- Contribute with clinical and project team members to the internal approval of the plan by governing bodies at platform (eg: RAfS) and cross platforms level (eg: STRC, CRSF, jSRC,...)
- Propose alternative trials design options, bringing innovative approaches where it adds value with the support of the Statistical Innovation team.
- Lead the cross-functional team through GO/NoGo criteria and evaluate probability of technical success.
- Contribute with project team members (ie: clinical, pharmacovigilance, regulatory,...) to gain Health Authorities acceptance of the plans, accountable from a statistical standpoint. Seek support from the Biostat Franchise Lead as needed.
- Oversee for his/her project the execution of the respective clinical trials: Data capture, Randomization, Statistical Analysis Plan, Analyses deliveries for primary and secondary objectives (efficacy, immunogenicity, safety). May be in charge of the most complex/priority study in the project.
- Communicate internally the trials results (Key Results Memo) and work cross-functionally (ie: clinical, safety, immunology,...) to the scientific interpretation of the results and evaluation of strategic impact on the plan.
- Contribute to the external communication of the study results to Health Authorities
- Accountable for the statistical aspects of the submission for marketing authorization or label improvement:
- ensure appropriate and quality data analyses are available efficiently to demonstrate the vaccine benefits-risks and support the label claims
- ensure quality of the clinical data CDISC packages are delivered and comply with Health Authorities (eg: FDA, PMDA, CDE, KFDA,..) expectations
Act as
- Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards
- Represent Sanofi Vaccines in cross-company activities such as consortiums or professional associations
- The Senior Project Biostatistics Lead operates in a worldwide context with GBS contributors located in different sites (eg: France, US, China, India,...), with different cultures.
- The Senior Project Biostatistics Lead has no direct reports but indirect ones delivering more on the operational side, requiring the incumbent to demonstrate leadership in engaging and communicating.
Context of the job/major challenges - (S)He interacts with other GBS teams, Clinical, Regulatory, Global Program Head, Regulatory, Immunology, Medical Writing, Data Management
- S(H)e has regular interactions with Sr R&D Leaders in communicating complex statistical concepts. S(H)e represents Sanofi Vaccines for external activities.
Dimensions/Scope - In his/her role of Senior Project Biostatistics Lead, the incumbent is accountable for all the biostatistics aspects related to the development, submission, launch and life cycle management of a medium vaccine project (5-7 clinical studies and global submission in key markets) or, a major vaccine program with support from the Biostatistics Franchise Lead.
- The incumbent will need to lead indirectly 6-12 FTEs for delivering the different project activities. S(He) makes trade-off decision on the priorities with the global project team, where there is conflict, to ensure deliveries according to Vaccines GBU scorecards. S(He) makes decision in any cross-functional initiatives where representing the platform.
About You Education/experience - Ph.D. in Biostatistics, Mathematics or related discipline is require. Minimum 6 years biostatistics experience in pharmaceutical industry OR
- MS in Biostatistics, Mathematics or related discipline is required. Minimum 8 years biostatistics experience in pharmaceutical industry
- Proven experience in clinical development or post-marketing activities
- Demonstrate strong project management & interpersonal skills
- Broad knowledge and good understanding of advanced statistical concepts and techniques
- Able to take on the asset statistical clinical aspects through regulatory interactions, submission and marketing authorization
- Effective English oral and written communication skills
Core Competencies - Strive of Results
- Act for Change & Innovation
- Commit to Customers
- Cooperate Transversally
- Thinking Strategically
- Make Decisions
Job Specific Competencies - Scientific Rigor, Organization skills
- Strategic Influencing skills
- Communication and Interpersonal skills
- Ability to work in a team
- Computer skills (SAS, R, Office)
Why Choose Us?- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Tags
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