Job Title: Senior/Principal Statistical Programmer

Overview:

A leading biopharmaceutical organization is seeking a skilled Senior or Principal Statistical Programmer to lead statistical programming efforts across clinical studies. This role requires advanced SAS programming expertise, a strong command of CDISC standards (SDTM, ADaM), and a collaborative mindset. The successful candidate will play a key role in preparing high-quality, submission-ready datasets and deliverables for regulatory submissions and study reporting.

Key Responsibilities:

• Serve as the lead programmer on clinical studies, managing both internal programming efforts and activities outsourced to CROs or external vendors.
• Develop, validate, and maintain SAS programs for data transformation, statistical analysis, and reporting purposes.
• Create and validate datasets in accordance with CDISC standards (SDTM, ADaM) and regulatory submission requirements, including define.xml files.
• Produce and verify tables, listings, and figures (TLFs) for clinical study reports and scientific publications.
• Partner with cross-functional teams including biostatistics, data management, clinical operations, and safety to ensure accuracy and integrity of clinical data.
• Provide programming support for regulatory submissions and agency interactions.
• Drive the development and implementation of standardized programming tools, macros, and automation workflows to improve team efficiency and consistency.
• Ensure adherence to Good Programming Practices (GPP), ICH guidelines, and internal SOPs.

Qualifications:

• Advanced degree (Master’s or higher) in Biostatistics, Statistics, Computer Science, Mathematics, or a related discipline.
• Minimum of 5 years’ experience in statistical programming within clinical research, with proficiency in SAS; experience with R is advantageous.
• At least 2 years of therapeutic area experience in oncology within a clinical trial environment.
• Strong knowledge of CDISC standards, including SDTM and ADaM, as well as experience with define.xml and Pinnacle 21.
• Familiarity with electronic data capture (EDC) platforms, such as Medidata Rave.
• Deep understanding of clinical development processes and regulatory expectations.
• Excellent attention to detail with a proven ability to prioritize and manage multiple projects.
• Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.