5+ years of experience in software development for clinical trials using SAS
Proficient in SAS programming; familiarity with other languages is a bonus
Strong understanding of statistics and the drug development lifecycle
Previous experience as a lead programmer for New Drug Applications (NDAs) or Biologics License Applications (BLAs)
Experience managing both internal contractors and external vendors such as CROs
Responsibilities
Develop CDISC-compliant datasets for regulatory submissions
Create or review software systems for clinical data displays, including tables and graphs
Assist statisticians by proposing algorithms for analysis requests
Develop software validation procedures and test plans
Participate in multi-disciplinary team meetings to represent programming efforts
Full Job Description
Summary: s a Clinical SAS Programmer, you will be responsible for attending multi-disciplinary team meetings to represent the programming function. You will create or review and approve programming plans at study and project levels, providing input on key study-related documents produced by other functions. Key Responsibilities:
Developing CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
Creating or reviewing software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
ssisting statisticians by suggesting algorithms to address client analysis requests.
Developing software validation procedures and test plans
Requirements :
Minimum years of experience in developing software for clinical trials using the SAS system.
Skilled in programming with SAS. Knowledge of additional programming languages a plus.
Good knowledge of statistics and drug development process.
Experience as a lead programmer for NDAs/BLAs.
Experience overseeing the work of internal contractors and external vendors (CROs).
