Statistical Programming Manager

4 weeks ago


Bronx, United States Takeda Pharmaceutical Company Ltd Full time

A growing biopharmaceutical company is looking for a Statistical Programming Manager with experience in program analysis programs, quality control checks and various SAS procedures. As a manager, you will also lead and organize study level programming and oversight activities for analysis of clinical trial data. Other essential skills include creating standard macros for clinical trial data, preparing deliverables for regulatory submission to FDA/EMA/PMDA and providing support for regulatory questions. This position is an excellent opportunity to work with a supportive and dynamic team to help improve patient lives.

Responsibilities:

  • Lead and organize study level programming and oversight activities for analysis of clinical trial data, ensuring quality and timeliness
  • Prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies
  • Create standard macros that can be adapted to multiple studies
  • Perform statistical analysis using SAS.

Qualifications:

  • Master's degree in Math, Computer Science, or related field or foreign academic equivalent plus 6 years of related experience OR Bachelor's degree in Math, Computer Science, or related field or foreign academic equivalent plus 8 years of related experience.
  • Strong programming skills in SAS.
  • Experience in program analysis programs and quality control checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials.
  • Ability to prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies and provide support for regulatory questions.
  • Excellent communication skills and ability to work effectively in a team-oriented environment.

Location: Lexington, MA

We are an equal opportunity employer and welcome everyone regardless of their race, ethnicity, national origin, gender, sexual orientation, religion, disability, or age.



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