Senior Project Biostatistics Lead- Vaccines

Sanofi•Waltham, MA

6d•Onsite

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 require. 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
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 (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

Benefits

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.

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