Sanofi · 1 week ago
Senior Project Biostatistics Lead- Vaccines
Waltham, MA
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expSanofi is an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. They are seeking a Senior Project Biostatistics Lead to oversee all statistical aspects of clinical development and medical affairs plans for vaccine projects, ensuring quality and scientific validity while collaborating with cross-functional teams.
Health CareLife SciencePharmaceuticalTherapeutics
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
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
Qualification
Required
Ph.D. in Biostatistics, Mathematics or related discipline is required. 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
Strive of 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)
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-14
Company data provided by crunchbase