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Senior Manager, Statistical Programming Lead

1 month ago

Lexington, Massachusetts, United States Takeda Full time
Takeda Development Center Americas, Inc.

We are seeking a highly skilled Senior Manager, Statistical Programming to join our team in Lexington, MA.

Key Responsibilities:
  • Develop and implement programming plans for clinical study results, regulatory submissions, and data standards.
  • Collaborate with cross-functional teams to create SDTM and ADAM datasets following CDSIC guidelines.
  • Provide programming support for FDA meetings, Advisory committee meetings, and ad-hoc requests for publications and posters.
  • Handle and program efficacy data, including creating primary endpoints in various therapeutic areas.
  • Plan, organize, and program integrated summary of safety and efficacy data from multiple studies, including Phase 1-4.
Requirements:
  • Bachelor's degree in Statistics, Biostatistics, or a related field, or foreign equivalent degree plus 6 years of related experience.
  • Strong programming skills, including experience with clinical data standards and regulatory submissions.
  • Excellent communication and collaboration skills, with the ability to work effectively in a team environment.
What We Offer:
  • Up to 100% remote work allowed from anywhere in the U.S.
  • Full-time position with a competitive salary range of $224,000 - $258,000 per year.

Apply online at https://www.takeda.com/careers and search for Req #R.