Remote, 12-month contract with potential to extend, directly supporting a sponsor
The Senior Statistical Programmer responsibilities include but are not limited to:
- Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
- Serve as the lead programmer in support of NDAs, sNDAs. Provide programming support for the preparation of integrated reports, submissions, and post-submission activities.
- Produce timely, high quality, and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
- Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
- Convert, verify, and integrate multiple sources of incoming data for the creation of analysis datasets.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
- Contribute to the creation, maintenance, and validation of standards for programming tools, outputs, and macros.
- Contribute to the creation, maintenance, and validation of programming tools and macros.
- Implement the filing of study documentation to the standard required according to processes and acceptable for audit.
Education, Experience, and Skills:
- Bachelor’s degree or higher
- Minimum of 7 years experience in leading and supporting statistical programming activities in clinical research for all phases of clinical trials, supporting global trials.
- Experience with regulatory filings, including global submissions
- Extensive knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, FDA/ICH, 21 CFR part 11, and other guidance documents and policies related to clinical trials and operations requirements
- Extensive knowledge of and experience with CDISC standards including SDTM and ADaM dataset specifications and Define-XML
- Ability to lead teams across 1-2 complex projects and assess resource needs
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