Sr Statistical Programmer SDTM, ADAM & TLFs

Sr Statistical Programmer SDTM, ADAM & TLFs

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

• Proven expertise in end-to-end clinical statistical programming (

  SDTM, ADAM & TLGs

  ).
• Extensive programming experience in

  SAS

  or other required software, preferably in a clinical trial environment.
• Undergraduate degree, preferably in a scientific or statistical discipline.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.
• Strong project management skills to manage multiple projects and timelines.
• Experience in performing validation programming and troubleshooting.