Spark Life Solutions, Inc.
SENIOR STATISTICAL PROGRAMMERS
Spark Life Solutions, Inc., San Francisco, CA, United States
Roles & 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
- Other duties as needed
- 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