Senior Project Biostatistics Lead (Associate Director) - Vaccines

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

• 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.
• Able to take on the asset statistical clinical aspects through regulatory interactions, submission and marketing authorization.
• Effective English oral and written communication skills.

Context of the job/major challenges

• Interacts with other GBS teams, Clinical, Regulatory, Global Program Head, Regulatory, Immunology, Medical Writing, Data Management
• Has regular interactions with Sr R&D Leaders in communicating complex statistical concepts.
• Represents Sanofi Vaccines for external activities.

Dimensions/Scope

• In his/her role of Senior Project Biostatistics Lead, the incumbent is accountable for all the biostatistics aspects related to the development, submission, launch and life cycle management of a medium vaccine project (5-7 clinical studies and global submission in key markets) or, a major vaccine program with support from the Biostatistics Franchise Lead.
• The incumbent will need to lead indirectly 6-12 FTEs for delivering the different project activities.
• Makes trade-off decision on the priorities with the global project team, where there is conflict, to ensure deliveries according to Vaccines GBU scorecards.
• Makes decision in any cross-functional initiatives where representing the platform.

Education/experience

• Ph.D. in Biostatistics, Mathematics or related discipline is require.
• Minimum 6 years biostatistics experience in pharmaceutical industry OR MSc 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
• Cope Transversally
• Think 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 its 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.