Senior Manager, Statistical Programming

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Job Description

Takeda Development Center Americas, Inc. is seeking a Senior Manager, Statistical Programming in Lexington, MA with the following requirements: Bachelor’s degree in Statistics, Biostatistics or related field or foreign equivalent degree plus 6 years of related experience. Prior experience must include: Experience in Creating Programing plans, evaluation and reporting of clinical study results, in regulatory submissions to FDA and EMA agencies in different Therapeutic area; Programing experience in Clinical data standards, creating both SDTM and ADAM datasets following CDSIC guidelines; Experience in programing support for FDA meetings, Advisory committee meetings along with performing Ad-hoc requests for publications, posters, and other needs; Experience in handling and programing efficacy data including creating primary endpoints in different Therapeutic area; Experience in planning, organizing, handling, and programing integrated summary of safety and efficacy data from multiple studies including Phase 1-4. Up to 100% remote work allowed from anywhere in the U.S.

Full time. $224,000 - $258,000 per year.

Apply on-line at https://jobs.takeda.com and search for Req #R0134645.

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