Design, develop, and validate SAS programs for clinical trial data.
Create analysis datasets (ADaM), tables, listings, and figures (TLFs) in accordance with CDISC standards.
Work with biostatisticians and data managers to interpret statistical analysis plans and ensure regulatory compliance.
Perform quality control checks and resolve discrepancies in datasets and outputs.
Ensure documentation is accurate and audit-ready for regulatory submissions (FDA, EMA).
Lead and mentor junior programmers on the team when needed.
Requirements:
Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, or a related field.
5+ years of hands-on experience in statistical programming within the pharmaceutical/biotech/CRO industry.
Strong proficiency in Base SAS, SAS/Macro, SAS/Graph, and SAS/STAT.
Experience with CDISC standards (SDTM, ADaM).
Familiarity with regulatory submission requirements (e.g., FDA, EMA).
Excellent problem-solving skills and attention to detail.
Strong communication and project management skills.
Nice to Have:
Experience with SAS Viya, R, or Python is a plus.
Previous involvement in eCTD submissions.
Exposure to therapeutic areas such as oncology, cardiology, or rare diseases.
#J-18808-Ljbffr