Senior Manager, Statistical Programming Lead
1 week ago
We are seeking a highly skilled Senior Manager, Statistical Programming to join our team in Lexington, MA. As a key member of our team, you will be responsible for leading the development and implementation of statistical programming plans, ensuring the accuracy and quality of clinical study results, and supporting regulatory submissions to FDA and EMA agencies.
Key Responsibilities:- Develop and implement statistical programming plans to support clinical study results
- Lead the creation of SDTM and ADAM datasets following CDSIC guidelines
- Support FDA meetings, Advisory committee meetings, and perform ad-hoc requests for publications, posters, and other needs
- Handle and program efficacy data, including creating primary endpoints in different therapeutic areas
- Plan, organize, handle, and program integrated summary of safety and efficacy data from multiple studies, including Phase 1-4
- Bachelor's degree in Statistics, Biostatistics, or related field or foreign equivalent degree
- 6 years of related experience
- Up to 100% remote work allowed from anywhere in the U.S.
- Full-time position
- $224,000 - $258,000 per year
Apply online at [insert link] and search for Req R.
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