Clinical SAS Programmer

Company: Katalyst HealthCares & Life Sciences
Location: Charlotte
Posted on: March 19, 2023

Job Description:

Responsibilities:

• 
  
• Collaborate with internal and external functions to plan and execute programming deliverables.
  
• Develop and execute statistical analysis and reporting deliverables in a timely and high-quality manner.
  
• Review or author SDTM and ADaM datasets specifications for datasets programming.
  
• Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for ADaM datasets, fit-for-purpose analysis, and TLFs.
  
• Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
  
• Provide programming support for adhoc analysis and for preparation of publications, including manuscripts and posters etc.
  
• Review key study-related documents including but not limited to SAP, annotated case report form, data management plan, database specifications, EDC data structures specs
  
  Requirements:
  
  
  • 
    
  • Bachelor's degree in Life Science, Statistics, Mathematics, or Computer Sciences is required. Master's degree preferred. Minimum of 3 years of SAS programming experience within a Pharma / Biotech or CROSolid SAS programming skills and experience with CDISC, SDTM, ADaM and Pinnacle 21.
    
  • Good programming skill in MACRO is needed. Experience in the analysis of complex oncology clinical trial data.
    
  • Knowledge of immuno-oncology is a plus
    
  • Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH)
    
  • Strong knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.)
    
  • Prior experience filing a BLA or NDA preferred. This position can be based either in our Woburn office or be a remote rOur Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
    
  • Remote c candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ , every 4-6 weeks or as business needs require .
    

Keywords: Katalyst HealthCares & Life Sciences, Charlotte , Clinical SAS Programmer, Other , Charlotte, North Carolina