Sr Statistical Programmer SDTM, ADAM & TLFs

Job Summary:

The Sr. Statistical Programmer will be responsible for end-to-end statistical programming in clinical trials, including SDTM, ADaM datasets, and tables, listings, and figures (TLFs). The role involves collaborating with biostatisticians, sponsors, and project teams to ensure high-quality programming outputs, compliance with regulatory guidelines, and efficient project delivery.

Key Responsibilities:

• Develop custom programming code using SAS or other software to generate summary tables, listings, graphs, and derived datasets according to SAP and programming specifications.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies.
• Maintain organized, complete, and up-to-date project documentation, testing, and verification/quality control programs.
• Manage multiple projects, set priorities, and adapt daily workload according to project timelines.
• Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements.
• Anticipate and address potential programming issues to establish efficient programming practices.
• Prepare and contribute in internal meetings, sponsor meetings, kickoff meetings, and bid defense meetings.
• Act as lead statistical programmer, directing programming activities of other personnel and monitoring progress on deliverables.
• Review project documentation such as SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs.
• Provide feedback to project team members to reduce inefficiencies and improve programming quality.
• Mentor programming personnel, develop training materials, and guide new associates in programming processes.
• Transfer deliverables and perform other work-related duties as assigned.
• Minimal travel may be required.

Qualifications:

• 5+ years of experience in Clinical Statistical Programming.
• Expertise in end-to-end programming, including SDTM, ADaM, and TLFs.
• Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
• Excellent written and verbal communication skills; ability to read, write, speak, and understand English.