Statistical Programmer II

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

• Develop, validate, and document SDTM and ADaM datasets, as well as tables, listings, and figures (TLFs) in accordance with statistical analysis plans, CDISC standards, regulatory requirements, and internal SOPs. Maintain clear traceability and ensure auditreadiness across all deliverables.
• Support and independently contribute to study programming activities, including ownership of assigned domains or workstreams. Lead programming tasks for smaller studies or substudies under guidance from senior or lead programmers, ensuring timely, consistent, and highquality outputs.
• Collaborate effectively with crossfunctional study teams-including statisticians, data managers, programmers, and project managers-to ensure efficient communication, issue resolution, and delivery of programming components. Communicate progress, risks, and technical issues clearly in both written and verbal form.
• Perform independent validation and quality control, including review of datasets, TLFs, programming specifications, and CDISC define.xml components. Assist in QC of define packages and contribute to submissionrelated documentation.
• Troubleshoot and resolve complex data and programming issues with minimal oversight, proposing appropriate solutions and ensuring consistent application of standards and best practices throughout the programming workflow.
• Contribute to process improvements through the development, enhancement, or maintenance of standard macros, tools, and templates, while mentoring or supporting junior programmers in standards, methods, and validation practices.
• Participate in data structure and study setup activities, including review of annotated case report forms and database design, ensuring alignment with downstream SDTM, ADaM, and analysis needs.

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.
• Statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferred; experience in CNS trials helpful.
• 2 to 5 years experience with SAS programming, preferred.
• Knowledge of SAS functionality & procedures.
• Technical knowledge and experience with SDTM, ADaM, CDISC controlled terminology desirable.
• Excellent communication skills (oral and written).
• Strong time management skills and the ability to work under tight deadlines.
• Excellent organizational skills.
• Able to work as part of a team or independently as needed.
• Experience working effectively & efficiently from a remote location is desirable.
• Able to adhere to standard operating procedures.
• High attention to detail, with a focus on quality, reproducibility, and traceability in all deliverables (analysis datasets and output.
• Comfortable working across functional teams (e.g., clinical, data management, biostatistics, medical writing).
• Ability to travel <10%.

Department Biostatistics Role Statistical Programmer Locations Remote, US Remote status Fully Remote Employment type Full-time