Associate Director, Biostatistics

Type of

Contract:

Full-time Employment / Unlimited

Job Requisition

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 member of the Global Biometrics Department, the Associate Director, Biostatistics leads the development and implementation of robust statistical strategies supporting Medical Affairs and Health Economics & Outcomes Research (HEOR) initiatives for one or more oncology products. As an individual contributor with significant strategic influence, this role partners closely with Medical Affairs, HEOR, Clinical Development, and Regulatory to shape evidence generation strategies across the product lifecycle.

This role ensures statistical rigor and integrity of Health Technology Assessment (HTA), real-world evidence (RWE), Medical Affairs and HEOR studies, and publications, and provides high-quality clinical evidence inputs to health economic evaluations and payer submissions.

Primary Responsibilities

• Lead statistical strategy for Medical Affairs and HEOR evidence generation plans across assigned products, ensuring alignment with medical, regulatory, and market access objectives.
• Provide statistical leadership for Integrated Evidence Generation Plans (IEGP), Joint Scientific Consultations (JSC), and Joint Clinical Assessment (JCA) dossiers.
• Collaborate with HEOR partners and contribute clinical evidence to value dossiers and payer submissions, ensuring alignment with EU HTA Regulation requirements and other payer expectations.
• Proactively identify evidence gaps and propose innovative study designs and analytical methodologies.
• Monitor evolving HTA requirements, regulatory guidance, and industry standards; recommend adjustments to internal practices to ensure compliance and competitiveness.
• Provide statistical leadership for HTA-related analyses, post-marketing studies, retrospective and observational studies, registry studies, indirect treatment comparisons, and patient-reported outcome research.
• Author and review statistical analysis plans (SAPs), including table, listing, and figure (TLF) shells. Oversee execution of statistical analyses, ensuring methodological rigor, quality control, and appropriate interpretation of results.
• Review protocols, study reports, briefing materials, and publications to ensure scientific robustness and consistency.
• Partner with Medical Affairs to design and analyze studies that support scientific communication and evidence dissemination.
• Represent Biostatistics on cross-functional medical and evidence generation teams, influencing decision-making by clearly articulating statistical perspectives.
• Support regulatory and payer interactions involving real-world evidence or outcomes-based data packages, including responding to statistical inquiries.
• Plan and prioritize statistical activities across projects; assess resource needs and ensure efficient utilization of available capacity.
• Provide oversight of CROs and external statistical vendors to ensure adherence to methodological standards and regulatory expectations.
• Contribute to departmental process improvements and development or revision of quality documents.
• Support publication strategy through statistical review of abstracts, posters, and manuscripts.
• Provide guidance and support interpretation of statistical findings to internal stakeholders and external experts.
• Provide statistical leadership for clinical development studies, as assigned.

Education and Required Skills

• Ph.D. in Biostatistics, Statistics, or a closely related field with a minimum of 5 years of relevant pharmaceutical industry experience. Master’s degree may be considered with minimum of 8 years of experience.
• Experience in oncology preferred.
• Advanced knowledge of statistical methodologies applicable to clinical development, Medical Affairs, and HEOR evidence generation.
• Demonstrated expertise in real-world evidence, post-approval studies, indirect treatment comparisons, and HTA-related submissions.
• Experience contributing statistical inputs to regulatory or payer interactions strongly preferred.
• Proficiency in SAS and R strongly preferred.
• Strong working knowledge of applicable regulatory guidance (ICH, FDA, EMA) and HTA frameworks (e.g., EU-HTA, ISPOR).
• Demonstrated ability to independently determine appropriate study designs and analytical strategies.
• Ability to respond to regulatory or external inquiries.
• Proven ability to manage CRO partnerships and ensure adherence to best practices.
• Demonstrated sound judgment and decision-making, with the ability to evaluate business impact, follow through on decisions, and adapt as priorities change.
• Excellent communication skills, including the ability to present complex statistical concepts clearly to non-statistical audiences.

Travel and Location

• Some…