Statistical Programmers (SAS) are responsible for creating and validating statistical programs, including datasets and outputs, following CRC procedures.  These positions generate accurate, complete, and consistent outputs by transforming raw clinical trial data into datasets, analyzing data, and providing Tables, Listings, and Figures (TLFs) while ensuring deliverables that meet projected timelines. The positions will regularly collaborate with clinical operations and data management teams, as well as external partners and clients.

The Senior Statistical Programmer provides experienced technical expertise to plan, track, and coordinate programming deliveries and the development of integrated programming solutions serving the full spectrum of statistical programming needs, as well as provide technical expertise and leadership to the department, liaise with other functions to complete projects and provide guidance, mentorship, and technical oversight.

Essential Duties & Responsibilities

• Lead the development, validation, and documentation of CDISC‑compliant SDTM and ADaM datasets, ensuring full traceability from raw clinical data through statistical outputs. Independently interpret study protocols, SAPs, and data standards to translate clinical objectives into programmed deliverables.

• Program and perform independent QC of complex TLFs for interim analyses, final study reports, regulatory submissions, and sponsor deliverables, ensuring accuracy, reproducibility, and alignment with statistical requirements.

• Serve as the primary programming point of contact for assigned studies, providing technical leadership and working closely with statisticians, data managers, medical writers, and project stakeholders in a fast‑paced environment to manage timelines, risks, and cross‑functional communication.

• Own and oversee study‑level or domain‑level programming deliverables, ensuring consistency, traceability, and adherence to CDISC standards, regulatory expectations, and internal SOPs. Lead programming activities for studies, sub‑studies, or complex workstreams with minimal oversight.

• Conduct rigorous QC and peer review of programming outputs developed by other team members, ensuring compliance, quality, and alignment with specifications, define.xml metadata, and reviewer’s guides.

• Identify, investigate, and resolve complex data or programming challenges, proactively assessing potential timeline or quality impacts and implementing effective technical solutions.

• Develop and maintain study‑specific and standardized programming tools, including macros, templates, and documentation, to enhance efficiency, scalability, and best practices across the programming function.

• Support regulatory submission readiness, contributing to define.xml packages, annotated CRFs, reviewer’s guides, and responses to agency queries for assigned studies.

• Mentor and develop junior and mid‑level programmers, providing guidance on CDISC standards, validation practices, efficient programming techniques, and high‑quality documentation.

• Contribute to department‑level process improvements, helping shape programming standards, workflows, and tools for a growing statistical programming team.

• Ensure all deliverables meet high standards for quality, consistency, and audit readiness, following SOPs, regulatory expectations, and established quality frameworks.

Qualifications

• 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 to effectively perform the job functions.

• 5 plus years of statistical programming experience within the biotech, pharmaceutical or CRO industry, preferably with prior experience 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 in a remote, team-based environment and comfortable with virtual collaboration tools.

• Excellent written and verbal communication skills, and able to explain technical concepts to non-programmers and cross-functional stakeholders.

• Strong interpersonal and teamwork skills, with a collaborative mindset and the ability to work independently and prioritize across multiple projects.

• High attention to detail, with a focus on quality, reproducibility, and traceability in all deliverables (analysis datasets and output).

• Demonstrated ability to follow standard operating procedures (SOPs), adhere to project timelines, and contribute to continuous improvement of programming processes.

• Proactive problem-solver and critical thinker with a willingness to adapt and thrive in a growing, fast-paced CRO environment.

• Able to manage multi-tasks and priorities in a fast-paced, dynamic environment with shifting timelines and evolving sponsor needs.

• Able to make complex programming and data-related decisions independently.

• Able to anticipate analytical needs, understand downstream impacts of programming decisions, and proactively identify gaps in data and specifications

• Comfortable working across functional teams (e.g., clinical, data management, biostatistics, medical writing) and shifting between strategic and tactical tasks quickly.

• Must demonstrate flexibility and adaptability — able to pivot between tasks, troubleshoot issues efficiently, and take initiative in a small, collaborative team setting. 

• Ability to travel <10%.