Senior Project Biostatistics Lead- Vaccines

About the Job

Job Title: Senior Project Biostatistics Lead
- Vaccines

Location: Waltham, MA

Lead Biostatistician for a 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 teams are exploring new technologies to protect people and promote healthy communities.

• Act as a Senior Biostatistics Expert at vaccine project level: develop the end-to-end clinical development plan for the vaccine with other clinical/medical and global project team members.
• Contribute with clinical and project team members to the internal approval of the plan by governing bodies at platform and cross-platform levels.
• Propose alternative trial design options, bringing innovative approaches where it adds value with the support of the Statistical Innovation team.
• Lead the cross-functional team through GO/No
  
  Go criteria and evaluate probability of technical success.
• Contribute with project team members to gain Health Authorities acceptance of the plans, accountable from a statistical standpoint. Seek support from the Biostat Franchise Lead as needed.
• Oversee execution of the respective clinical trials: data capture, randomization, statistical analysis plan, analyses deliveries for primary and secondary objectives (efficacy, immunogenicity, safety). May lead the most complex/priority study in the project.
• Communicate trial results internally (Key Results Memo) and work cross-functionally to interpret results and evaluate strategic impact on the plan.
• Contribute to external communication of the study results to Health Authorities.
• Accountable for the statistical aspects of submissions for marketing authorization or label improvement: ensure appropriate and quality data analyses are available to demonstrate vaccine benefits-risks and support label claims.
• Ensure quality of the clinical data CDISC packages are delivered and comply with Health Authorities expectations (e.g., FDA, PMDA, CDE, KFDA).

Act as:

• Represent statistics in cross-functional working groups and contribute to process optimization and statistics standards.
• Represent Sanofi Vaccines in cross-company activities such as consortiums or professional associations.
• Operate in a worldwide context with GBS contributors across sites (e.g., France, US, China, India) with different cultures.
• Have no direct reports but may lead indirectly, delivering the operational work and demonstrating leadership in engaging and communicating.

• Interacts with other GBS teams and stakeholders (Clinical, Regulatory, Global Program Head, Immunology, Medical Writing, Data Management).
• Regularly communicates complex statistical concepts to Sr R&D Leaders and represents Sanofi Vaccines in external activities.

• Accountable for all biostatistics aspects related to 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.
• Indirectly lead 6-12 FTEs for delivering project activities and make trade-off decisions with the global project team to ensure deliveries per Vaccines GBU scorecards.

Education / Experience

• Ph.D. in Biostatistics, Mathematics or a related discipline is required. Minimum 6 years biostatistics experience in the pharmaceutical industry OR
• MS in Biostatistics, Mathematics or a related discipline is required. Minimum 8 years biostatistics experience in the pharmaceutical industry.
• Proven experience in clinical development or post-marketing activities.
• Demonstrated strong project management and interpersonal skills.
• Broad knowledge and understanding of advanced statistical concepts and techniques.
• Ability to handle asset statistical clinical aspects through regulatory interactions, submission and marketing authorization.
• Effective English oral and written communication skills.

• Strive for Results
• Act for Change & Innovation
• Commit to Customers
• Cooperate Transversally
• Thinking Strategically
• Make Decisions

• Scientific Rigor, Organization skills
• Strategic Influencing skills
• Communication and Interpersonal skills
• Ability to work in a team
• Computer skills (SAS, R, Office)

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover opportunities to grow your talent and drive your career, through promotions or lateral moves, domestically or internationally.
• Enjoy a rewards package that…