Senior Project Biostatistics Lead (Associate Director) - Vaccines
Sanofi · Waltham, MA · 3 wk ago
On-siteInformation TechnologyFull-time
About the role
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.
Main Responsibilities
- 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 (e.g.: RAFS) and cross platforms level (e.g.: 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 (e.g.: 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 (e.g.: 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 (e.g.: FDA, PMDA, CDE, KFDA, …) expectations
Representations
- 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
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.
About You
- Education/experience: 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
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.