Job Summary:
Syneos Health is seeking an experienced Principal Statistical Programmer to join its global biopharmaceutical solutions team in Pune. This pivotal role involves leading statistical programming projects for clinical trials, utilizing SAS and CDISC standards, and mentoring a team of programmers. The position offers the opportunity to work on complex global projects and contribute to regulatory submissions, ensuring data quality and compliance with industry standards.
Key Responsibilities:
Develop custom SAS programs for summary tables, listings, graphs, and derived datasets.
Perform validation programming and resolve discrepancies with project teams.
Ensure all outputs meet quality standards and regulatory guidelines (ICH, GCP).
Maintain complete, inspection-ready project documentation and QC records.
Lead concurrent programming deliverables with accountability for timelines.
Mentor junior programmers and provide technical training.
Participate in study kickoffs, sponsor meetings, and bid defense meetings.
Develop and review Statistical Analysis Plans (SAP) and programming specifications.
Contribute to the development of SOPs, guidelines, and programming tools.
Serve as subject matter expert for CDISC SDTM and ADaM standards.
Conduct compliance reviews of deliverables for regulatory submissions (e.g., DEFINE.XML).
Required Skills & Qualifications:
Bachelor’s degree in Science, Statistics, or related field (or equivalent experience).
Extensive SAS programming experience in clinical trial environments.
Proven ability to lead complex and global programming projects.
Strong knowledge of CDISC SDTM and ADaM standards.
Experience with regulatory agency submissions preferred.
Mentoring and leadership abilities.
Excellent communication and English proficiency (verbal & written).
Perks & Benefits:
Career development programs and clear progression pathways.
Technical and therapeutic area training.
Supportive and inclusive work culture promoting work-life balance.
Global projects and exposure to top pharmaceutical clients.
Peer recognition and total rewards program.
Company Description:
Syneos Health is a global biopharmaceutical solutions leader, offering integrated clinical development and commercialization services. Known for driving innovation in clinical research and data management, Syneos Health partners with the world's top pharmaceutical and biotechnology companies to accelerate drug development and delivery to patients.
Work Mode:
On-site – Pune, Maharashtra, India
Call-to-Action:
Ready to make an impact in clinical trial programming? Apply now to join Syneos Health and advance your career in a global, innovation-driven environment.
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