Senior Project Biostatistics Lead- Vaccines

Role Summary

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.

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 (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

Qualifications

• 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

Skills

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