Biostatistics Lead, Next Generation Immunology

Role Summary

Biostatistics Lead, Next Generation Immunology. Location: Cambridge, MA; Morristown, NJ. Lead development and conduct of statistical analyses for Sanofi Specialty Care sponsored clinical studies (Phase 3/4 and exploratory analyses), providing strategic input to cross-functional Medical Affairs teams and contributing to abstracts and manuscripts. Requires strong disease area expertise, leadership, and collaboration across global teams.

Responsibilities

• Understand existing studies, datasets, and analyses to guide future analyses and harmonize statistical strategies across departments.
• Lead, design, conduct, QC, and report analyses for multiple products and therapeutic areas, including hands-on programming and supervising external contractors; present findings to internal and external stakeholders; prepare listings and tables for abstracts, posters, slide decks, and manuscripts.
• Co-lead forums on analytical/data concepts and prioritize post-hoc analyses, bringing in disease area expertise.
• Influence strategic planning for brand plans related to medical and scientific communications.
• Provide consultation and guidance to cross-functional groups on manuscripts, posters, slide presentations, abstracts, exploratory analyses, and lifecycle management projects.
• Establish collaborative relationships with cross-functional teams, Medical Affairs leaders, alliance partners, affiliates, external writers, and authors.
• Respond to journal editor/reviewer comments with Publication Leads; review abstracts/manuscripts and serve as an expert on statistical methods.
• Support statistical analyses for dossiers or responses to HTA/payer bodies as needed.
• Assign tasks and supervise internal statistical and programming resources; review presentations and training materials.
• Provide consultant-level support for HEOR/HEVA feasibility studies and review concepts/protocols for studies as requested; collaborate with external alliance partners as needed.
• Maintain expertise in current statistical methods; attend scientific congresses to provide statistical support and gain competitive insights.
• Assist the Head of Biostatistics as requested.

Qualifications

• PhD in Biostatistics or Statistics (or similar) with at least 6 years of experience in statistical analyses from human studies, including Phase 3 or 4 data (pre-planned and post-hoc). OR
• Master's degree in Biostatistics or Statistics (or similar) with at least 10 years of experience in statistical analyses from human studies, including Phase 3 or 4 data (pre-planned and post-hoc).

Knowledge and Skills

• In-depth knowledge of statistical methods for clinical studies (time-to-event, recurrent event, binary, count, categorical data, longitudinal data analysis, missing data methods, nonparametric methods, ANCOVA, meta-analysis, etc.).
• Proficient in SAS and R, CDISC standards; hands-on statistical programming experience.
• Strong leadership, project management, and communication skills; ability to work with non-statisticians.
• Relevant disease area knowledge from industry trials and data reporting; collaborative, fast-paced, and able to manage changing priorities.