Principal Statistical Programmer – SDTM, ADaM & TLF
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104967
Job Overview
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization that accelerates the development and commercialization of innovative therapies. By uniting clinical development, medical affairs, and commercial expertise, Syneos Health delivers high-quality, data-driven solutions that address complex regulatory and market challenges.
We are seeking an experienced Principal Statistical Programmer with deep expertise in SDTM, ADaM, and TLF programming to lead complex statistical programming activities and support late-phase clinical development and regulatory submissions.
Experience Required
Minimum 8+ years of hands-on experience in Clinical SAS Programming
Proven leadership experience as a Lead or Principal Statistical Programmer
Extensive experience in SDTM, ADaM, and TLF development
Strong exposure to safety and efficacy data programming
Prior experience supporting regulatory submissions
Immediate joiners preferred
Key Responsibilities
Statistical Programming & Delivery
Develop high-quality SAS programs to generate analysis datasets, tables, listings, and figures in accordance with SAPs and programming specifications
Create and review complex programming specifications ensuring efficiency, accuracy, and compliance with sponsor and regulatory requirements
Perform validation programming and resolve discrepancies in collaboration with biostatisticians and project teams
Ensure timely and accurate delivery of concurrent programming deliverables
Technical Leadership & Oversight
Act as the lead statistical programmer, directing and monitoring the work of programming team members
Review SAPs, mock shells, annotated CRFs, SDTM/ADaM specifications, and database designs
Provide technical guidance to reduce rework and improve programming efficiency
Serve as a subject matter expert for CDISC standards, including SDTM, ADaM, and DEFINE.XML
Quality, Compliance & Inspection Readiness
Ensure compliance with SOPs, Work Instructions, ICH guidelines, and regulatory standards
Maintain complete, accurate, and inspection-ready documentation
Conduct compliance reviews of CDISC deliverables and regulatory submission packages
Support transfer of programming deliverables across internal and external stakeholders
Cross-Functional & Client Collaboration
Participate in sponsor meetings, project kickoffs, and bid defense meetings as the statistical programming representative
Proactively communicate programming status, risks, and mitigation plans to management
Collaborate with biostatistics teams to establish and enhance programming SOPs, standards, and best practices
Innovation, Mentoring & Standardization
Contribute to the development of standard programming tools, macros, and reusable code
Mentor and coach junior programmers through training, review, and feedback
Provide internal training on CDISC standards and evolving regulatory requirements
Stay current with industry standards and contribute updates to biometrics leadership
Qualifications & Skills
Education
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline
Equivalent professional experience will be considered
Technical Expertise
Advanced proficiency in Base SAS and SAS Macros
Strong working knowledge of SDTM, ADaM, TLF, ISS/ISE
Experience with R programming is a strong advantage
Oncology therapeutic area experience is preferred
Professional Skills
Excellent written and verbal communication skills in English
Strong analytical, organizational, and problem-solving abilities
Ability to manage multiple projects in a fast-paced, global environment
Proven ability to work independently and lead technical discussions
Why Join Syneos Health
Opportunity to work on programs supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products
Exposure to global clinical development and high-impact regulatory submissions
Strong focus on career development, technical excellence, and leadership growth
Inclusive, collaborative culture built on diversity and innovation
About Syneos Health
Over the past five years, Syneos Health has supported more than 200 clinical studies across 73,000 sites and 675,000+ clinical trial patients globally. With a workforce of 29,000+ professionals across 110 countries, Syneos Health continues to shape the future of biopharmaceutical development.
Disclaimer
The responsibilities listed are not exhaustive and may be modified based on business needs. Syneos Health reserves the right to determine equivalent qualifications and experience. This posting does not constitute an employment contract. The company is committed to equal employment opportunity and compliance with applicable employment legislation, including reasonable accommodations.
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