Description
Syneos Health is seeking a Statistical Programmer (SDTM, ADAM, TLF) to join their Clinical Solutions team. The successful candidate will use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications. The ideal candidate will have 8+ years of programming experience in Clinical Statistical Programming, strong experience in SDTM, ADAM & TLF, SDTM/ADAM specs writing, and experience in Oncology efficacy endpoints/outputs.
Responsibilities:
- Develop custom programming code to generate summary tables, data listings, graphs, and derived datasets
- Perform validation programming and work with other programmers, biostatisticians, and project team members to resolve discrepancies or findings
- Maintain well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs
- Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes
- Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
- Conduct effective internal meetings and distribute relevant information in advance
- Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business
- Act as the lead statistical programmer and direct the programming activities of other programming personnel
- Review project documentation and provide feedback to the appropriate project team members
- Participate in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative
- Contribute to the mentoring of programming personnel and maintain a good working knowledge of clinical drug development, industry standards, and electronic submission requirements
Qualifications:
- 8+ years of programming experience in Clinical Statistical Programming
- Strong experience in SDTM, ADAM & TLF, SDTM/ADAM specs writing
- Experience in Oncology efficacy endpoints/outputs
- Experience in submissions to a regulatory agency preferred
- Experience in R programming
- Excellent written and verbal communication skills