Associate Director, Biostatistics

Servier Pharmaceuticals; Boston (MA); Hybrid; USD 164,000 - 194,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Flexible time off

401(k)

Job summary

Servier in the U.S. is seeking an Associate Director, Biostatistics in Boston to lead statistical activities across assets and indications within the Global Biometrics Department.

You will collaborate with clinical, regulatory, and evidence generation stakeholders to ensure regulatory relevance and scientific validity. The role involves directing analyses, planning timelines, contributing to study design and regulatory documents, and interacting with authorities to support submissions.

Qualifications

• Ph.D. in Biostatistics or closely related field required with a minimum of 5 years of relevant pharmaceutical experience.
• Master’s degree in Statistics or related field may be considered with minimum of 8 years of experience.
• Proficiency in SAS is strongly preferred.
• Working knowledge of regulatory guidance documents (ICH, FDA, EMEA) and industry standards.
• Direct regulatory filing experience is preferred for roles supporting clinical development.

Responsibilities

• Provide statistical support on assets or indications by directing execution of analyses and reviewing outputs.
• Plan and track activities and timelines across projects; justify resource needs.
• Input into product development or HEOR/HTA strategies with innovative designs.
• Collaborate with Biostatistics team and CROs to develop statistical approaches.
• Select appropriate statistical methods for study design and data analysis; review SAPs and reports.
• Engage with regulatory authorities and external bodies on trial statistical issues.
• Guide teams on conclusions ensuring regulatory and external meeting alignment.

Skills

SAS proficiency

Statistical knowledge

Regulatory communication

Collaboration

Education

Ph.D. in Biostatistics

Master’s degree consideration with 8+ years

Tools

SAS

Job description

Date posted: Sep 12, 2026

City: Boston

Country/Region: US

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 12320

Associate Director, Biostatistics

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.

Job Description

Role Summary

As a key member of the Global Biometrics Department, the Associate Director, Biostatistics will work on one or more assets or indications, contributing to all statistical aspects of the clinical development plan, individual studies, submissions, or evidence generation activities. This role partners closely with clinical, regulatory and other evidence generation stakeholders to provide quality, regulatory relevance, and scientific validity.

Primary Responsibilities

• Provide statistical support on one or more assets or indications by directing the execution of statistical analyses, review of statistical outputs, and ensuring accurate results interpretation, collaborating closely with physicians, evidence generation stakeholders, or other cross-functional leads as appropriate on the interpretation of clinical results
• Plan and track activities and timelines across projects; justify resource needs and ensure efficient utilization of available capacity
• Provide input into product development, medical affairs or HEOR/HTA strategy by suggesting innovative designs and decision-making tools
• Partner with other Biostatistics department members or consultants, to develop effective statistical approaches applicable to project.
• Select appropriate statistical methods for study design and data analysis, review protocols and statistical methods and results sections for study reports
• In partnership with other Biometrics members, interact with regulatory authority, other external bodies or scientific community on clinical trial statistical issues
• Provide guidance to the clinical, regulatory, and/or evidence generation teams on conclusions and inferences from the data package, ensuring statistical perspective is integrated into regulatory and external meetings, and delivering data packages aligned with submission requirements or key decision-making
• Responsible for the statistical aspect of regulatory documents such as CSRs, as well as integrated reports and summary documents
• Collaborate in departmental process improvement initiatives and development/revision of quality documents
• Monitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in compliance
• Contribute to publication plan by reviewing abstracts, posters, and manuscripts to support Medical Affairs.
• Contribute to the establishment and maintenance of common formats and templates for key Biostatistics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings)

Candidate Profile

Education And Required Skills

• Ph.D. in Biostatistics or closely related field is required with a minimum of 5 years of relevant pharmaceutical experience. Master’s degree in Statistics or related field may be considered with minimum of 8 years of experience.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques
• Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
• Proficiency in SAS is strongly preferred
• Ability to determine appropriate designs and analyses for clinical trials and/or evidence generation
• Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs as needed
• Must have a working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices
• Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA) and industry standards applicable to clinical development or ement generation
• Direct regulatory filing experience is preferred for roles supporting clinical development
• Ability to respond to regulators or other external inquiries
• Ability to take appropriate action in all dealings with CRO partners to ensure best practices are followed
• Demonstrated sound judgment and decision-making, with the ability to evaluate business impact, follow through on decisions, and adapt as priorities change

Travel and Location

• Some domestic and international travel required
• On-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to Boston

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.

Salary Range

The salary range for this role is $164,000-194,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).

• medical
• dental
• vision
• flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)
• 401(k)
• life and disability insurance
• recognition programs
• other great benefits (all benefits are subject to eligibility requirements)

Nearest Major Market: Boston