Principal Statistical Programmer
Role Overview
Syneos Health's Clinical Solutions team applies drug development expertise to customer solutions across clinical development and commercialization.
The Principal Statistical Programmer supports clinical research programming and collaborates with programmers, biostatisticians, sponsors, and project teams.
Key Skills for This Role
Full Job Posting
Location
- The position is remote and based in Maharashtra, India.
Description
Syneos Health's Clinical Solutions team applies drug development expertise to customer solutions across clinical development and commercialization.
The Principal Statistical Programmer supports clinical research programming and collaborates with programmers, biostatisticians, sponsors, and project teams.
Job responsibilities
- Use SAS or other software to create summary tables, listings, graphs, and derived datasets according to statistical analysis plans and programming specifications.
- Perform validation programming, resolve discrepancies, and keep project teams informed of progress and issues.
- Follow SOPs, work instructions, and regulatory guidance while maintaining inspection-ready documentation and quality-control records.
- Manage priorities and timelines across multiple projects and deliver concurrent programming work on time.
- Develop dataset and output specifications, anticipate programming issues, and reduce rework through clear definitions.
- Lead meetings, track action items, and communicate deliverable status and risks to management.
- Lead statistical programming activities, direct other programming personnel, and monitor deliverables.
- Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.
- Participate in sponsor, kickoff, and bid defense meetings as the statistical programming representative.
- Mentor programming personnel through training, work review, feedback, and process guidance.
- Maintain knowledge of clinical drug development, industry standards, and electronic submission requirements.
About Syneos Health
Syneos Health describes itself as a fully integrated life sciences services organization supporting drug development and commercialization.
The company highlights career development, technical and therapeutic area training, peer recognition, and an inclusive culture.
Requirements
- Maintain a good working knowledge of clinical drug development and industry standards.
- Maintain knowledge of electronic submission requirements and applicable regulatory guidelines such as ICH.
- Develop statistical programming specifications for datasets and outputs of varying complexity.
- Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.
- Demonstrate the ability to manage concurrent projects, timelines, priorities, and programming deliverables.
- Lead statistical programming activities and direct the work of other programming personnel.
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