Associate Director, Statistical Programming

Servier Pharmaceuticals

Boston (MA)

Hybrid

USD 165,000 - 200,000

Full time

14 days+

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Benefits offered by this job

Medical, dental, vision

Flexible time off

401(k)

Incentive programs

Job summary

Servier is seeking an Associate Director, Statistical Programming to lead programming activities across studies and assets. The role involves hands-on programming or oversight of outsourced deliverables, ensuring regulatory alignment and collaboration with statisticians and study teams.

You will mentor programmers, implement robust analysis processes, and ensure CDISC SDTM/ADaM compliance while coordinating with CROs and vendors to deliver timely, high-quality outputs for regulatory submissions.

Qualifications

Masters in Statistics, Engineering or relevant field with 8+ years in statistical programming.
Experience with SAS and CDISC ADaM/SDTM.
Knowledge of regulatory submission guidelines.
Strong study management and programming process expertise.
Ability to lead and mentor statistical programmers.

Responsibilities

Manage statistical programming deliverables across assets and oversee vendors.
Oversee development and QC of analysis datasets and outputs for individual studies and integrated analyses.
Ensure high-quality, traceable, timely outputs for regulatory needs.
Mentor statistical programmers.
Collaborate with statisticians and CROs to define analysis requirements.
Ensure CDISC compliance of SDTMs and ADaMs.
Forecast resource needs with portfolio programming lead.
Plan and track project activities and timelines.

Skills

SAS programming

CDISC SDTM/ADaM knowledge

Regulatory knowledge

Project management

Mentoring

Communication skills

Education

Masters in Statistics, Engineering or relevant field

Tools

SAS

Job description

Date posted: Jul 15, 2026

City: Boston

Country/Region: US

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 12318

Associate Director, Statistical Programming

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

The Associate Director, Statistical Programming leads statistical programming activities for multiple studies, an asset or an indication by performing hands-on programming or oversight of outsourced deliverables. This individual will ensure that the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures. The role will interact closely with the study statisticians and study team regarding statistical programming aspects.

Primary Responsibilities

Manage statistical programming deliverables on one or more assets or indications by managing study leads and oversee study activities and vendor oversight.

Oversee development and quality control or oversight plan of analysis datasets and outputs for individual study as well as integrated analyses.

Ensure study leads deliver high quality, traceability, reproducibility of study outputs and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.

Mentor statistical programmers with regards to programming activities and project management.

Independently implement routine and non-standard analysis algorithms for assigned projects or studies.

Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.

Ensure an efficient collaboration with all members of the clinical study team.

Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:

Clinical study reporting, e.g. ICH E3

Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11

Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards.

Ensure that the datasets (SDTMs and ADaMs) are CDISC compliant.

Support on the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.

Work with the portfolio programming lead to create forecasts for different studies and resource requirements.

Other Responsibilities

Participate in working groups (either inter department or cross functional).

Participate in the preparation of audit/inspection and could interact with auditors/inspectors.

Contribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., standard CRF pages, Tables, Figures and Listings).

Plan and track project activities, timelines across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.

Education And Required Skills

Masters in Statistics, Engineering or relevant field required with a minimum of 8 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry in clinical development desirable

Experience with statistical programming in Oncology desirable

Proficient in SAS

Good knowledge of CDISC ADaM and SDTM

Strong knowledge of relevant regulatory and data submission guidelines

Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions

Self-directed, technically strong, expert regarding statistical programming processes, management of statistical programmers at study level

Strong study management skills

Good negotiation and issue resolution skills

Ability to organize team work and prioritize and balance concurrent tasks and responsibilities.

Excellent time management skills

Ability to educate internal and external interfaces (CROs and contractors) on the statistical programming processes, and the underlying regulatory requirements

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 $165,000-$200,000. 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).