Description
Syneos Health is seeking a Principal / Senior Statistical Programmer (ADAM, TLF, SDTM). The successful candidate will be responsible for developing custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications.
Responsibilities:
- Develops custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets
- Performs validation programming and works with other programmers, biostatisticians, and project team members to resolve discrepancies or findings
- Maintains well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs
- Manages scheduling and time constraints across multiple projects, sets goals based on priorities, and adapts to timeline or priority changes
- Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
- Conducts effective internal meetings and distributes relevant information in advance
- Displays willingness to work with others and assist with projects and initiatives as necessary
- Acts as the lead statistical programmer and directs the programming activities of other programming personnel
- Reviews project documentation and provides feedback to project team members
- Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative
- Contributes to the mentoring of programming personnel and develops training courses
- Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements
- Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures
- Contributes technical expertise to the development of programming tools and macros for standardization and efficiency
- Performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets
Qualifications:
- 8+ years of experience in Clinical SAS Programming
- Strong expertise in Base SAS/SAS Macros, SDTM, ADAM & TLF programming, specs creation
- Hands-on experience with both Safety & Efficacy data
- Experience in Oncology therapeutic areas is preferred
- ISS/ISE experience and R programming skills are required
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English