Senior Manager, Biostatistics

SERVIER MONDE•Boston, MA

2d•$152,000 - $173,000•Hybrid

About The Position

As a member of the Global Biometrics Department, the Senior Manager, Biostatistics supports the development and implementation of robust statistical strategies for Medical Affairs and Health Economics & Outcomes Research (HEOR) initiatives for one or more oncology products. 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.

Requirements

Ph.D. in Biostatistics, Statistics, or a closely related field with a minimum of 2 years of relevant pharmaceutical industry experience. Master’s degree in Statistics or related field may be considered with minimum of 5 years of experience.
Experience in oncology preferred.
Expertise in statistical methodologies applicable to clinical development, Medical Affairs, and HEOR evidence generation.
Experience in real-world evidence, post-approval studies, indirect treatment comparisons, and HTA-related submissions.
Demonstrated leadership and mentoring capability.
Experience contributing statistical inputs to regulatory or payer interactions strongly preferred.
Proficiency in SAS and R strongly preferred.
Exceptional organizational skills and attention to details.
Project management skills with the ability to manage multiple competing priorities.
Familiarity with regulatory guidance (ICH, FDA, EMA) and HTA frameworks (e.g., EU-HTA, ISPOR).
Excellent communication skills, including the ability to present complex statistical concepts clearly to non-statistical audiences.

Responsibilities

Responsible for statistical support on Medical Affairs and HEOR evidence generation plans across assigned products, ensuring alignment with medical, regulatory, and market access objectives.
Serve as the primary Biostatistics representative 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.
Provide statistical support 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.
Provide oversight of CROs and external statistical vendors to ensure adherence to methodological standards and regulatory expectations.
Champion developmental process improvement initiatives and development/revision of procedures (SOPs) and work instructions as needed.
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.
Advise and implement appropriate new statistical developments by keeping abreast of current issues and developments.
Provide statistical support for clinical development studies, as assigned.