Sr. Manager, 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.

Role Summary

The Sr Manager, Statistical Programming is responsible for the development of statistical programming on the study level by performing hands-on programming or oversight of outsourced programming deliverables. Ensure the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures.

Interact with the study statisticians and study team regarding statistical programming aspects.

Primary Responsibilities

• Provide programming support for the development or QC of:
  • SDTMs
  • ADaM specifications
  • ADaM datasets
  • TLFs
• Manage statistical programming activities for a clinical study related to CSR, iDMC, Adhoc analysis and publications etc.
• Ensure high quality, traceability, reproducibility, and timeliness of statistical programming deliverables to meet expectations and regulatory requirements
• 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
• Deliver exemplary performance and solve complex technical problems to inspire other programmers
• Ensure an efficient collaboration with all the 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 the datasets (SDTMs and ADaMs) are CDISC compliant
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation

Other Responsibilities

• Guarantee that all relevant programming documents are part of the Trial Master File
• Contribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., standard CRF pages, Tables, Figures and Listings)
• Understand, follow, and ensure adherence to programming SOPs. Maintain awareness of industry standards, regulatory requirements, guidelines and any other relevant Servier SOPs
• Help the project lead to plan and track study activities and timelines

Education and Required Skills

• Masters in Statistics, Engineering, or relevant field required with at least 5 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry. Clinical Development experience preferred
• 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
• 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's 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 (2-3 times per year)
• On-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to Boston

Job Description

Candidate Profile

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…