Sr Statistical Programmer SDTM, ADAM & TLFs

We are seeking a Sr Statistical Programmer SDTM, ADAM & TLFs to join a leading biopharmaceutical solutions organization. This role is for a skilled professional who can use SAS and other software to develop custom programming code, ensure quality outputs, and act as a lead programmer for multiple projects, driving success by delivering therapies to patients faster.

Roles and Responsibilities

• Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets ( TLFs ).
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies.
• Keep project team members informed of programming progress and issues.
• Follow applicable SOPs, WIs , and relevant regulatory guidelines ( ICH ).
• Maintain well-organized and up-to-date project documentation and programs, ensuring readiness for inspection.
• Manage scheduling and time constraints across multiple concurrent projects.
• Develop specifications for datasets and outputs of any complexity based on statistical and sponsor requirements.
• Anticipate and address potential programming issues to ensure efficient programming.
• Conduct effective internal meetings and ensure action items are completed.
• Negotiate and establish accurate time estimates for project activities and complete them within the allotted timeframe.
• Act as the lead statistical programmer, directing the programming activities of other personnel and monitoring their progress.
• Review project documentation like the Statistical Analysis Plan , mock shells, and programming specifications, providing feedback to reduce inefficiencies.
• Participate in sponsor meetings, kickoff meetings, and bid defense meetings as required.
• Contribute to the mentoring of programming personnel by developing training courses and providing feedback to new associates.
• Transfer deliverables upon project completion.

Skills Required

Skills Required

statistical programming, Sas, Programming, Troubleshooting, Sdtm, ADAM