Senior Statistical Programmer
3 weeks ago
We are seeking a highly skilled Senior Statistical Programmer - Clinical Trials to join our team at Spark Life Solutions, Inc.
In this role, you will be responsible for performing data manipulation, analysis, and reporting of clinical trial data, as well as programing and generating tables, listings, and graphs (TLGs).
The ideal candidate will have 15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companies, and a strong submissions experience (BLA, NDA/sNDA and EMA) and end-to-end programming experience.
We offer a competitive salary range of $140,000 - $170,000 per year, depending on qualifications and experience.
Key Responsibilities:
- Perform data manipulation, analysis, and reporting of clinical trial data
- Program and generate tables, listings, and graphs (TLGs)
- Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets
- Review, and comment on CRFs, annotated CRFs, and edit checks and related documents
- Participate in study team meetings and address issues that may affect statistical programming
- Validate and document SAS programs and output
- Create SDTM and ADaM Datasets and related documentation
- Fulfill ad-hoc programming requests
Education & Experience:
- 15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companies
- Strong submissions experience (BLA, NDA/sNDA and EMA) and end-to-end programming experience
- Knowledge and experience working with CDISC Standards (must have expertise in both SDTM/ADaM, developing specifications for both)
- Demonstrated ability performing all levels of programming activities for a clinical project
- Experience working in the Cardiovascular or Neuromuscular areas is a plus
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