Statistical Programmer Consultant

Overview

• Collaborate with Biometrics staff to provide programming support for Phase 1 to Phase 3 clinical studies.
• Develop and maintain SDTM/ADaM datasets, TLFs, and dataset specifications for clinical trials.
• Ensure timely and accurate programming deliverables aligned with project strategies and timelines.
• Support project integration and disease monitoring initiatives through statistical programming expertise.
• Identify and address changes in project requirements impacting deliverables.
• Collaborate with cross-functional teams including Clinical Operations, Data Management, and Regulatory staff.
• Contribute to process improvement strategies and identify tools to enhance efficiency and quality.
• Provide technical input for documents developed by biostatisticians, data managers, and medical writers.

Key Responsibilities & Duties

• Perform programming activities across multiple projects and therapeutic areas, internally and externally by CROs.
• Create and review annotated CRFs mapped to SDTM datasets for clinical trials.
• Balance conflicting priorities while promoting communication and alignment with strategic objectives.
• Act as a role model by setting high standards for quality, creativity, and project ownership.
• Develop and maintain data review and reporting tools alongside Biometrics and other functions.
• Provide technical guidance for statistical applications and process improvement strategies.
• Collaborate with cross-functional teams to meet deliverables and timelines for statistical data analysis.
• Identify and implement new tools to improve efficiency and quality in statistical programming.

Job Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, or a related discipline required.
• Minimum of 1-5 years of clinical trial programming experience in biotechnology or pharmaceutical industries.
• Proficiency in SAS programming and experience with statistical software such as R and S-Plus.
• In-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.
• Strong organizational skills and ability to prioritize tasks effectively.
• Self-directed, technically proficient, and capable of leading statistical programming projects strategically.
• Excellent communication skills for collaborating with cross-functional teams and providing technical input.
• Experience in process improvement and identifying tools to enhance programming efficiency.