Sr Statistical Programmer SDTM, ADAM

2 weeks ago

Pune, Maharashtra, India Syneos Health Full time
Job Description

Job Summary:

The Sr. Statistical Programmer will be responsible for end-to-end statistical programming in clinical trials, including SDTM, ADaM datasets, and tables, listings, and figures (TLFs). The role involves collaborating with biostatisticians, sponsors, and project teams to ensure high-quality programming outputs, compliance with regulatory guidelines, and efficient project delivery.

Key Responsibilities:

- Develop custom programming code using SAS or other software to generate summary tables, listings, graphs, and derived datasets according to SAP and programming specifications.
- Ensure outputs meet quality standards and project requirements.
- Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies.
- Maintain organized, complete, and up-to-date project documentation, testing, and verification/quality control programs.
- Manage multiple projects, set priorities, and adapt daily workload according to project timelines.
- Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements.
- Anticipate and address potential programming issues to establish efficient programming practices.
- Prepare and contribute in internal meetings, sponsor meetings, kickoff meetings, and bid defense meetings.
- Act as lead statistical programmer, directing programming activities of other personnel and monitoring progress on deliverables.
- Review project documentation such as SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs.
- Provide feedback to project team members to reduce inefficiencies and improve programming quality.
- Mentor programming personnel, develop training materials, and guide new associates in programming processes.
- Transfer deliverables and perform other work-related duties as assigned.
- Minimal travel may be required.

Qualifications:

- 5+ years of experience in Clinical Statistical Programming.
- Expertise in end-to-end programming, including SDTM, ADaM, and TLFs.
- Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience.
- Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
- Excellent written and verbal communication skills; ability to read, write, speak, and understand English.

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