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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 :
- Creating Programming plans, evaluation and reporting of clinical study results, in regulatory submissions to FDA and EMA agencies in different Therapeutic areas.
- Programming experience in Clinical data standards, creating both SDTM and ADAM datasets following CDISC guidelines.
- Programming support for FDA meetings, Advisory committee meetings along with performing Ad-hoc requests for publications, posters, and other needs.
- Handling and programming efficacy data including creating primary endpoints in different Therapeutic areas.
- Planning, organizing, handling, and programming 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.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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