Statistical Programmer

Responsibilities

• Collaborate with biostatisticians and cross-functional study team members to deliver statistical analysis and reporting outputs in line with project timelines
• Review study documents including statistical analysis plans (SAPs), CRFs, database specifications, and data transfer specifications
• Create and/or review SDTM/ADaM mapping specifications and annotated CRFs (aCRFs)
• Generate and/or validate SDTM and ADaM datasets, including associated Define.xml and reviewer’s guides
• Develop and validate tables, figures, and listings (TFLs) to support clinical study analyses, regulatory submissions, conferences, and publications
• Audit the quality, integrity, and consistency of analysis datasets, including cross-study analyses where applicable
• Develop SAS programs and macros to automate dataset generation and reporting deliverables
• Contribute to process improvements and enhancements of the statistical programming environment
• Participate in study team meetings and represent statistical programming in cross-functional discussions

Qualifications

• Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific discipline, with 0–2 years of experience in statistical programming within the pharmaceutical/biotech industry or a CRO
• Proficiency in SAS programming, preferably with experience in a clinical trial environment
• Working knowledge of CDISC standards (SDTM and ADaM)
• Prior experience or exposure to oncology studies is preferred
• Strong analytical, problem-solving, and organizational skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams