Senior Statistical Programmer

3 weeks ago


Little Falls, United States Planet Pharma Full time

Sr. Statistical Programmer and above Location: Remote - based in US Direct Hire/Permanent Placement Compensation Expectations: Competitive Market Rate

Education: Minimum of 5 years of highly relevant CRO industry experience with a relevant PhD. Minimum of 8 years of highly relevant CRO industry experience with a relevant Masters. Minimum of 11 years of highly relevant CRO industry experience with a relevant Bachelors.

Top 5 Skills: Proficiency in SAS Programming is required, familiarity with R is preferred. All therapeutic areas will be considered, with a strong preference for candidates with experience in oncology. The number of studies an individual will lead concurrently will vary based on their level of experience. Candidates with expertise in SDTM, ADaM, and TLF are sought after. While possessing a master's degree is highly beneficial, it is not a strict requirement.

Key Accountabilities: Design and specify study data tabulation models and analysis data models for clinical trials or for the integration of clinical trial data from multiple trials (e.g. ISS and ISE datasets). These designs and specifications are completed in accordance with common industry standards and conventions, statistical requirements and specifications, and/or clinical trial sponsor’s requirements. Generate complete and efficient analysis data models following approved dataset designs or specifications. Perform independent validation of datasets created by other programmers or statisticians. Develop SAS programming codes and generate complete and accurate statistical output reports of trial data in well-defined formats. Develop SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians. Develop and test SAS codes for clinical trial database logical checks and reports for ongoing data review. Document data and programming information in accordance with corporate SOPs and guidelines. Archive clinical trial data (study data tabulation models and analysis data models) and programming information in accordance with corporate archival SOPs and guidelines. Develop and provide expertise in other programming and system administration areas when required. Provide technical guidance and support to less experienced Statistical Programmers. Contribute to the continuous improvement of the statistical programming processes and procedures. Contribute to the establishment of therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer. Contribute to the establishment of client specific programming standards/conventions/procedures for assigned clients when required.

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