About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.

Role Summary

As a key leader within the Global Biometrics Leadership Team, the Senior Director, Biostatistics is responsible for both leading a team of biostatisticians supporting the neuro-oncology pipeline and advancing statistical innovation across the organization. This role provides strategic oversight of statistical contributions to clinical development and ensures the use of appropriate statistical methodologies. The Senior Director, Biostatistics also represents the department in key regulatory and cross-functional forums and integrates statistical expertise into decision-making.

Primary Responsibilities

• Lead and develop a high-performing statistical team, providing career growth opportunities, hiring, and talent retention. Partner with the department head to assess and define evolving resourcing and capability needs.
• Drive statistical innovation across the department, internal cross-functional collaborations, and external collaborations.
• Shape product development strategy by suggesting innovative designs and decision-making tools.
• Select and apply optimal statistical methods for clinical trial design, analysis, and interpretation.
• Oversee execution of statistical analyses, reviews statistical outputs and guarantees results interpretation.
• Serve as key Servier statistical representative to regulatory authorities, regarding statistical issues in clinical trial design, analysis, and data presentations as well as communications.
• Provide strategic guidance to clinical and regulatory teams regarding conclusions and inferences from the data package, ensuring statistical perspective is integrated into regulatory submissions and external communications or meetings.
• Works independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to projects.
• Review and approve regulatory documents, including protocols, IBs, CSRs, and submission packages as well as integrated reports and summary documents.
• Contribute to the interpretation of analysis results to team members through direct product responsibility or subordinates.
• Lead or contribute to key departmental process improvement initiatives, including the development or revision of SOPs and best practices.
• Ensure alignment with regulatory, industry, and company standards, monitoring changes and updating internal practices accordingly as needed to maintain compliance.

Education and Required Skills

• Ph.D. in Biostatistics required with 12+ years of relevant pharmaceutical experience, including experience in Oncology and interactions with regulatory bodies.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques.
• Demonstrated strong skills in statistical innovation. Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management.
• Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making).
• Ability to determine appropriate designs and analyses for clinical trials.
• Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
• Working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices.
• Working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA).
• Direct regulatory filing experience preferred.
• Ability to respond to regulator’s inquiries for products undergoing registration and approved products.
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
• Managerial experience preferred.

Travel and Location

• Some domestic and international travel required
• Hybrid approximately 2-3 days per week in the office.

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.