Senior Project Biostatistics Lead- Vaccines

Role Summary

Lead Biostatistician for a medium complexity vaccine project in clinical development and/or post-marketing. Responsible for all statistical aspects of clinical development and medical affairs plans, studies and submissions, ensuring quality, external relevance, 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 and cross-platform levels
• Propose alternative trial 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 the project the execution of the respective clinical trials: Data capture, Randomization, Statistical Analysis Plan, analyses deliveries for primary and secondary objectives (efficacy, immunogenicity, safety)
• Communicate internally the trial 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, ensuring quality data analyses and CDISC packages

Qualifications

• Required: Ph.D. in Biostatistics, Mathematics or related discipline; minimum 6 years biostatistics experience in the pharmaceutical industry
• Required: MS in Biostatistics, Mathematics or related discipline; minimum 8 years biostatistics experience in the pharmaceutical industry
• Proven experience in clinical development or post-marketing activities
• Demonstrate strong project management and interpersonal skills
• Broad knowledge and understanding of advanced statistical concepts and techniques
• Able to take on asset statistical clinical aspects through regulatory interactions, submission and marketing authorization
• Effective English oral and written communication skills

Education

• Ph.D. in Biostatistics, Mathematics or related discipline (required) or
• MS in Biostatistics, Mathematics or related discipline (required)

Skills

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

Core Competencies

• Strive for Results
• Act for Change & Innovation
• Commit to Customers
• Cooperate Transversally
• Thinking Strategically
• Make Decisions