Senior Project Biostatistics Lead- Vaccines

Sanofi • Waltham, MA

110d • $147,000 - $212,333

About The Position

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.

Requirements

• 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.

Nice To Haves

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

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 and cross platforms level.
• 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 to gain Health Authorities acceptance of the plans, accountable from a statistical standpoint.
• 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.
• Communicate internally the trials results and work cross-functionally 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 quality of the clinical data CDISC packages are delivered and comply with Health Authorities 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.

Benefits

• High-quality healthcare.
• Prevention and wellness programs.
• At least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees