Develop SAS programs to produce tables, listings, and data for phase I-IV clinical trials.
Perform data review, checks, query, extraction, and cleaning using SAS/BASE.
Generate CDISC compliant SDTM, ADaM datasets, data specifications and define.xml documentation for clinical studies.
Report statistical methods and results to clinical teams.
Write and review protocols, statistical analysis plans, table and listing mocks/shells and statistical reports.
Review CRFs for consistency with protocols and statistical analysis plan.
Master Degree in Statistics or Biostatistics
1 year work experience in SAS programming and statistical analysis in clinical trials
1 year work experience in the pharmaceutical or clinical research environment
Software/Programming Language Requirements: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/ODS, SAS/SQL, SAS/GRAPH, SAS/report
SAS Base Certificate/SAS Advance Certificate
Familiar with CDISC standards and knowledge of clinical trials from Phase I-IV
Additional Salary Information: N/A
About Prosoft Software Inc
Prosoft Clinical is a contract research organization focused on pharmaceutical product design and development. Since 1995, Prosoft has been providing services to the pharmaceutical, biotech, and medical device industries in areas including dermatology, cardiovascular, respiratory, allergy, immunology, CNS and oncology. Our team has worked together for over 15 years and has a longstanding track record of excellence in bringing products to market.
We specialize in clinical services and software solutions for all of your clinical trial needs. Spanning all areas of drug development, including pre-clinical and clinical phases I-IV, Prosoft can help expedite your clinical trial needs – including regulatory and clinical operations, biostatistics, and data management.