Associate Director, Statistical Programming

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.

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 ensures that the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures. The role interacts closely with the study statisticians and study team regarding statistical programming aspects.

• Manage statistical programming deliverables on one or more assets or indications by managing study leads and overseeing 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 achieve 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.

• 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 situations.

• 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.
• Good negotiation and issue resolution skills.
• Ability to organize team work and prioritize and balance concurrent tasks and responsibilities.
• Ability to educate…