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Senior Manager, Biostatistics
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- Senior Manager, Biostatistics
- This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main responsibilities will include hands on day to day support of one or more clinical studies.
- The main activities would include review of the Protocols, eCRF, SDTM/ADAM specs review, SAP authoring, DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission.
- Engage in planning, methodology, and analysis for Phase 1-3 clinical studies, not limited to protocol development, sample size calculation, authoring of statistical analysis plans, data review, analysis implementation and interpretation
- Provide statistical/programming support for responses to regulatory authorities related to submission reviews
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