Biostatistics Lead, Next Generation Immunology

6+ years

USD 147,000.00 - 212,333.33

United States

10 Oct. 27, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📊 Biostatistics Lead – Next Generation Immunology

Location: Cambridge, Massachusetts & Morristown, New Jersey, USA 🇺🇸
Work Type: Onsite | Regular
Posted On: October 16, 2025
Closing Date: February 13, 2026
Salary Range: USD 147,000 – 212,333.33

🌍 About Sanofi

Sanofi is a global healthcare innovator, driven by a mission to transform lives through the miracles of science.
From rare diseases and immune challenges to neurological and hematologic disorders, we pioneer research, deliver life-changing therapies, and empower patients and healthcare professionals worldwide.

The Medical Excellence Team—a key part of Medical Operations & Effectiveness within Sanofi Specialty Care Global Medical Affairs—partners globally to build strategy, optimize engagement, and enhance the scientific and clinical impact of Sanofi’s Medical Affairs initiatives.

🎯 About the Role

As the Biostatistics Lead (Next Generation Immunology), you will play a strategic and hands-on role in driving statistical excellence for Phase 3 & 4 clinical studies and exploratory analyses.

You will collaborate across Medical Affairs, Publications, and Global Teams to design, execute, and interpret complex statistical analyses supporting scientific publications, congress presentations, and evidence-based communication strategies for Sanofi’s Immunology portfolio.

This position blends technical leadership, strategic influence, and cross-functional collaboration, with a focus on data-driven insights for marketed and pipeline products.

🧩 Main Responsibilities

🔹 Strategic Leadership

Lead statistical planning, design, and execution for exploratory and post-hoc analyses supporting Global Medical Affairs.
Contribute to strategic planning and brand initiatives, ensuring alignment between statistical deliverables and scientific communication goals.
Harmonize statistical approaches across functions to ensure consistency, accuracy, and innovation.
Influence analysis prioritization and design in cross-functional forums.

🔹 Statistical Analysis & Reporting

Perform, QC, and document statistical analyses for Phase 3/4 studies, registries, and post-marketing research.
Provide statistical input to manuscripts, abstracts, slide decks, and posters.
Present and interpret findings for internal teams, management, and external authors.
Apply innovative methods such as longitudinal data modeling, mixed-effects models, and meta-analysis.
Maintain audit-ready archives for all analysis plans, code, outputs, and reports.

🔹 Collaboration & Communication

Partner with Medical Affairs, HEOR, Publications, and Market Access to deliver data-driven insights.
Advise publication teams, respond to journal reviewer comments, and occasionally serve as a co-author.
Collaborate with external experts, alliance partners, and medical writers for publication readiness.
Support dossier analyses for HTA/payer submissions and evidence synthesis activities.

🔹 Leadership & Mentorship

Supervise internal statisticians/programmers and external contractors.
Provide training and guidance on statistical methodology and data interpretation.
Assist the Head of Biostatistics in departmental initiatives when required.
Attend scientific congresses to provide analytical support and gather insights on competitor methodologies.

🎓 Qualifications

Basic Qualifications

Ph.D. in Biostatistics/Statistics (or related field) with 6+ years of relevant experience,
or Master’s degree with 10+ years of experience.
Proven expertise in Phase 3–4 clinical trial analyses, both planned and post-hoc.
Strong hands-on experience in SAS, R, and CDISC standards.
Demonstrated leadership and project management skills in pharma or biotech.
Proficiency in explaining statistical concepts to non-statistical audiences.

Preferred Qualifications

Experience supporting Medical Affairs or HEOR/HEVA functions.
Prior work in Immunology or related therapeutic areas.
Experience with long-term extension study data and competitive market analysis.
Successful publication track record in peer-reviewed journals.
Vendor and project management experience, including budget oversight.

🧠 Key Knowledge & Skills

Expert knowledge of:
- Composite endpoints, ANCOVA, GEE, LME, nonparametric methods.
- Time-to-event and recurrent event analysis.
- Missing data and responder analyses.
- Data mining, meta-analysis, and statistical innovation.
Excellent verbal and written communication, collaboration, and problem-solving abilities.
Strong multitasking and adaptability in a fast-paced, cross-functional environment.

🌟 Why Choose Sanofi

Join a world-class team driving innovation in Next Generation Immunology.
Endless career mobility through global roles, promotions, and cross-functional growth.
Competitive compensation and a well-structured rewards package recognizing your contributions.
Comprehensive healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

⚖️ Equal Opportunity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers.
We value diversity and inclusion and prohibit discrimination based on race, gender, age, disability, sexual orientation, veteran status, or any protected characteristic.

🚀 Join Us

Step into a new era of science with Sanofi — where your expertise in biostatistics fuels innovation, shapes strategy, and impacts lives globally.

Pursue Progress. Discover Extraordinary.
Apply Now

📊 Biostatistics Lead – Next Generation Immunology

🌍 About Sanofi

🎯 About the Role

This position blends technical leadership, strategic influence, and cross-functional collaboration, with a focus on data-driven insights for marketed and pipeline products.

🧩 Main Responsibilities

🔹 Strategic Leadership

Lead statistical planning, design, and execution for exploratory and post-hoc analyses supporting Global Medical Affairs.
Contribute to strategic planning and brand initiatives, ensuring alignment between statistical deliverables and scientific communication goals.
Harmonize statistical approaches across functions to ensure consistency, accuracy, and innovation.
Influence analysis prioritization and design in cross-functional forums.

🔹 Statistical Analysis & Reporting

Perform, QC, and document statistical analyses for Phase 3/4 studies, registries, and post-marketing research.
Provide statistical input to manuscripts, abstracts, slide decks, and posters.
Present and interpret findings for internal teams, management, and external authors.
Apply innovative methods such as longitudinal data modeling, mixed-effects models, and meta-analysis.
Maintain audit-ready archives for all analysis plans, code, outputs, and reports.

🔹 Collaboration & Communication

Partner with Medical Affairs, HEOR, Publications, and Market Access to deliver data-driven insights.
Advise publication teams, respond to journal reviewer comments, and occasionally serve as a co-author.
Collaborate with external experts, alliance partners, and medical writers for publication readiness.
Support dossier analyses for HTA/payer submissions and evidence synthesis activities.

🔹 Leadership & Mentorship

Supervise internal statisticians/programmers and external contractors.
Provide training and guidance on statistical methodology and data interpretation.
Assist the Head of Biostatistics in departmental initiatives when required.
Attend scientific congresses to provide analytical support and gather insights on competitor methodologies.

🎓 Qualifications

Basic Qualifications

Ph.D. in Biostatistics/Statistics (or related field) with 6+ years of relevant experience,
or Master’s degree with 10+ years of experience.
Proven expertise in Phase 3–4 clinical trial analyses, both planned and post-hoc.
Strong hands-on experience in SAS, R, and CDISC standards.
Demonstrated leadership and project management skills in pharma or biotech.
Proficiency in explaining statistical concepts to non-statistical audiences.

Preferred Qualifications

Experience supporting Medical Affairs or HEOR/HEVA functions.
Prior work in Immunology or related therapeutic areas.
Experience with long-term extension study data and competitive market analysis.
Successful publication track record in peer-reviewed journals.
Vendor and project management experience, including budget oversight.

🧠 Key Knowledge & Skills

Expert knowledge of:
- Composite endpoints, ANCOVA, GEE, LME, nonparametric methods.
- Time-to-event and recurrent event analysis.
- Missing data and responder analyses.
- Data mining, meta-analysis, and statistical innovation.
Excellent verbal and written communication, collaboration, and problem-solving abilities.
Strong multitasking and adaptability in a fast-paced, cross-functional environment.

🌟 Why Choose Sanofi

Join a world-class team driving innovation in Next Generation Immunology.
Endless career mobility through global roles, promotions, and cross-functional growth.
Competitive compensation and a well-structured rewards package recognizing your contributions.
Comprehensive healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

⚖️ Equal Opportunity Statement

🚀 Join Us

Step into a new era of science with Sanofi — where your expertise in biostatistics fuels innovation, shapes strategy, and impacts lives globally.

Pursue Progress. Discover Extraordinary.
Apply Now

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Biostatistics Lead, Next Generation Immunology

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