Principal Statistical Programmer
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104549
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success across the clinical development lifecycle. By combining deep clinical, medical, and commercial expertise, Syneos Health delivers innovative solutions that address evolving global market and regulatory demands.
With a patient-centric Clinical Development model and operations across more than 110 countries, Syneos Health partners with sponsors to streamline development, enhance quality, and accelerate the delivery of life-changing therapies worldwide.
Role Overview
The Principal Statistical Programmer is a senior-level individual contributor and technical leader responsible for delivering high-quality statistical programming outputs for complex clinical trials. This role provides strategic programming expertise, oversees end-to-end programming activities, and ensures compliance with global regulatory standards, including FDA, EMA, ICH, and CDISC requirements.
The position plays a critical role in mentoring programming teams, leading cross-functional collaboration, and supporting regulatory submissions and sponsor interactions.
Key Responsibilities
Statistical Programming and Delivery
Develop and validate SAS and other statistical programming code to generate analysis datasets, summary tables, listings, and figures in accordance with Statistical Analysis Plans (SAPs) and programming specifications.
Ensure programming outputs meet quality, regulatory, and project-specific requirements.
Perform validation programming and resolve discrepancies in collaboration with biostatisticians and cross-functional project teams.
Maintain inspection-ready programming documentation, including testing, QC records, and version-controlled programs.
Project Leadership and Oversight
Act as the lead statistical programmer on assigned projects, directing and monitoring the work of other programming team members.
Manage multiple concurrent projects, proactively balancing timelines, priorities, and resource constraints.
Negotiate programming timelines, develop risk mitigation strategies, and communicate deliverable status to management and sponsors.
Ensure on-time delivery of all programming deliverables across studies and programs.
Technical Expertise and Standards Compliance
Develop and review specifications for datasets and outputs of varying complexity, ensuring clarity, accuracy, and efficiency.
Review key project documentation, including SAPs, mock shells, annotated CRFs, programming specifications, and database designs.
Serve as a subject matter expert for CDISC standards, including SDTM, ADaM, and Define.xml, and conduct compliance reviews for regulatory submissions.
Support electronic submission readiness and data transfer activities in accordance with regulatory requirements.
Collaboration, Mentoring, and Process Improvement
Represent statistical programming in sponsor meetings, study kickoffs, and bid defense discussions, as required.
Mentor and develop statistical programming staff through training, coaching, work review, and knowledge sharing.
Contribute to the development and maintenance of programming SOPs, guidelines, macros, and standardized tools to improve efficiency and consistency.
Participate in industry standards initiatives and communicate upcoming regulatory or CDISC changes to internal stakeholders.
Required Qualifications and Experience
Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related scientific discipline; advanced degree preferred.
8–12 years of statistical programming experience, preferably within a CRO, pharmaceutical, or biotechnology environment.
Extensive hands-on expertise in SAS programming for clinical trials, including leadership of complex, global studies.
Strong working knowledge of CDISC standards (SDTM, ADaM, Define.xml) and global regulatory submission requirements.
Prior experience supporting regulatory submissions to health authorities is strongly preferred.
Demonstrated experience mentoring and guiding statistical programmers in clinical trial processes and standards.
Excellent written and verbal communication skills in English, with the ability to interact effectively with sponsors and cross-functional teams.
Why Join Syneos Health
Opportunity to work on studies supporting the majority of newly approved FDA and EMA products.
Access to structured career development, leadership pathways, and technical training.
Collaborative, inclusive, and performance-driven work environment.
Exposure to global clinical programs and high-impact regulatory submissions.
Additional Information
This job description is not intended to be exhaustive. Syneos Health may assign additional responsibilities as business needs evolve. Equivalent combinations of education, skills, and experience may be considered. Employment terms comply with applicable local and international employment laws, including equal opportunity and reasonable accommodation requirements.
Role Summary
The Principal Statistical Programmer serves as a senior technical expert and programming leader, delivering high-quality statistical outputs for complex clinical trials. The role combines deep programming expertise, regulatory knowledge, project leadership, and mentoring to support successful clinical development and regulatory submissions across global programs.
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