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Senior Statistical Programming Manager

4 weeks ago

Boston, Massachusetts, United States Servier Laboratories Full time

As a key member of our team at Servier Laboratories, you will play a critical role in driving our mission to deliver innovative solutions in the Oncology space.

With a strong focus on statistical programming, you will be responsible for ensuring that our data analysis processes and deliverables are aligned with regulatory requirements.

Key responsibilities will include:

  • Leading the development of statistical programming processes and deliverables for multiple studies.
  • Collaborating with statisticians, local and Clinical Research Organization (CRO) programmers to define and implement analysis requirements.
  • Ensuring that statistical programming systems, processes, and deliverables are aligned with relevant regulatory requirements.

Requirements for this role include:

  • A Master's degree in Mathematics, Applied Mathematics, Statistics, Biostatistics, Clinical Research, Computer Science, or Engineering.
  • At least eight years of experience as a statistical programmer analyzing clinical trial data in biotech or pharmaceutical companies, or CRO providing programming services to biotech or pharmaceutical companies.
  • Experience with United States Food and Drug Administration (FDA), European Union's European Medicines Agency (EMA), or Japan's Pharmaceuticals and Medical Devices Agency (PMDA) submissions.
  • Knowledge of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) guidelines.

Servier Laboratories is committed to modeling diversity, equity, and inclusion within the industry. 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.

As an employee, you will be eligible for a competitive and comprehensive benefits package, including medical, dental, vision, flexible time off, 401(k), life and disability insurance, recognition programs, and more.