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
- 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.
