Senior Project Biostatistics Lead (Associate Director) - Vaccines
Sanofi
June 25, 2026
Remote friendly (Waltham, MA)
United States
$148,500 - $247,500 USD yearly
Clinical Research and Development
Main Responsibilities:
- Act as a Senior Biostatistics Expert for medium-complexity vaccine projects (one or several indications) across clinical development and/or post-marketing.
- Develop the end-to-end clinical development plan with clinical/medical/global teams; support internal approvals.
- Propose alternative trial design options and lead cross-functional teams through GO/NoGo criteria and technical success probability.
- Collaborate with clinical, pharmacovigilance, regulatory teams to gain Health Authority acceptance (statistical accountable).
- Oversee execution of clinical trials (data capture, randomization, Statistical Analysis Plan, analyses for primary/secondary endpoints: efficacy, immunogenicity, safety); may lead the most complex/priority study.
- Communicate results internally (Key Results Memo) and externally to Health Authorities; support submission/label improvements with quality data analyses and CDISC package compliance.
- Represent statistics in working groups and contribute to process optimization and statistics standards; represent the company in consortiums/professional associations.
Qualifications:
- Ph.D. in Biostatistics/Mathematics (6+ years pharma biostatistics) OR MS (8+ years pharma biostatistics).
- Proven experience in clinical development or post-marketing activities.
Required/Preferred Skills:
- Strong project management and interpersonal skills; advanced statistical concepts knowledge.
- Ability to manage regulatory interactions for submission/marketing authorization.
- Effective English oral/written communication.
- Computer skills (SAS, R, Office).
Benefits:
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Act as a Senior Biostatistics Expert for medium-complexity vaccine projects (one or several indications) across clinical development and/or post-marketing.
- Develop the end-to-end clinical development plan with clinical/medical/global teams; support internal approvals.
- Propose alternative trial design options and lead cross-functional teams through GO/NoGo criteria and technical success probability.
- Collaborate with clinical, pharmacovigilance, regulatory teams to gain Health Authority acceptance (statistical accountable).
- Oversee execution of clinical trials (data capture, randomization, Statistical Analysis Plan, analyses for primary/secondary endpoints: efficacy, immunogenicity, safety); may lead the most complex/priority study.
- Communicate results internally (Key Results Memo) and externally to Health Authorities; support submission/label improvements with quality data analyses and CDISC package compliance.
- Represent statistics in working groups and contribute to process optimization and statistics standards; represent the company in consortiums/professional associations.
Qualifications:
- Ph.D. in Biostatistics/Mathematics (6+ years pharma biostatistics) OR MS (8+ years pharma biostatistics).
- Proven experience in clinical development or post-marketing activities.
Required/Preferred Skills:
- Strong project management and interpersonal skills; advanced statistical concepts knowledge.
- Ability to manage regulatory interactions for submission/marketing authorization.
- Effective English oral/written communication.
- Computer skills (SAS, R, Office).
Benefits:
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.