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Senior Statistical Programmer

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Offer summary

BS in Stats, Math, Computer Sciences, 8+ years experience in Medical Device/Pharma/Biotech.

Plan, develop, test, validate, and maintain programs in SAS for clinical trials
Provide programming expertise, review and validate statistical programs, perform data analysis in collaboration

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Responsibilities:

Plan the execution of programs in statistical programming languages within project. Develop, test, validate, document, maintain and execute programs in SAS.
Provide programming expertise for clinical trials in programming, documentation, validation and review of summary tables, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statistician.
Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review.
Perform analysis in response to data requests in collaboration with designated statistician.

Requirements:

BS in Stats, Math, Computer Sciences.
8+ years of Experience working within Medical Device/Pharma/Biotech Solid SAS Programming Experience.
Excellent understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting.