Sr. Statistical Programmer

Responsibilities

• Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs.
• Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and client deliverables.
• Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis‑ready datasets and outputs.
• Act as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast‑paced environment.
• Conduct independent QC and peer review of programming deliverables to ensure accuracy, compliance, and reproducibility of results.
• Develop and maintain study‑specific programming specifications, documentation, and macros to streamline programming efficiency.
• Support regulatory submission readiness, including define.xml, reviewer's guides, and response to agency questions.
• Proactively identify and resolve data or programming issues that may impact timelines or analysis accuracy.
• Mentor and support junior programmers, fostering quality, consistency, and CDISC best practices across projects.
• Contribute to process improvement initiatives and template development for a growing statistical programming team.

• Bachelor’s or master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific discipline; or a combination of education, training and experience that enables effective performance in this role.
• 5+ years of statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferably in CNS trials.
• Experience leading programming efforts for clinical trials, including dataset development, TLF production, and QC oversight.
• Advanced proficiency in SAS, with hands‑on experience using CDISC SDTM and ADaM standards.
• Experience with R or Python for data manipulation, automation, or reporting is highly valued, though not required.
• Experience with regulatory submissions and standards, including Pinnacle 21, define.xml, and reviewer's guides.
• Experience working remotely and comfortable with virtual collaboration tools.
• Excellent written and verbal communication skills, and ability to explain technical concepts to non‑programmers and cross‑functional stakeholders.
• Strong interpersonal and teamwork skills, with the ability to work independently and prioritize across multiple projects.
• High attention to detail and focus on quality, reproducibility, and traceability in all deliverables.
• Demonstrated ability to follow SOPs, adhere to project timelines, and contribute to continuous improvement of programming processes.
• Proactive problem‑solver and critical thinker, willing to adapt and thrive in a fast‑paced CRO environment.
• Capable of managing multiple tasks and priorities in a dynamic environment with shifting timelines and evolving sponsor needs.
• Independent decision‑making ability on complex programming and data‑related decisions.
• Anticipate analytical needs, understand downstream impacts of programming decisions, and proactively identify gaps in data and specifications.
• Comfortable working across functional teams (clinical, data management, biostatistics, medical writing) and shifting quickly between strategic and tactical tasks.
• Demonstrate flexibility, adaptability, initiative, and the ability to troubleshoot efficiently in a collaborative team setting.

Seniority level:
Not Applicable |

Employment type:

Contract | Job function:
Information Technology | Industries:
Pharmaceutical Manufacturing