Principal Statistical Programmer (SDTM, ADaM, TLF) – Hybrid | Hyderabad & Gurugram
Location: India – Hyderabad (Hybrid)
Updated: Today
Job ID: 25103333
Position Overview
Syneos Health is seeking an experienced Principal Statistical Programmer with expertise in SDTM, ADaM, and TLF programming to support global clinical development projects. This hybrid position, based in Hyderabad or Gurugram, requires strong leadership capabilities, advanced SAS programming proficiency, and deep familiarity with CDISC standards.
As part of Syneos Health’s integrated biopharmaceutical solutions model, you will contribute to high-quality statistical programming deliverables that support regulatory submissions and clinical development workflows worldwide.
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization delivering tailored clinical, medical, and commercial services. With a global workforce of over 29,000 employees across more than 110 countries, the company focuses on operational excellence, process simplification, and improving outcomes for patients and customers.
Syneos Health promotes a culture of authenticity, diversity, professional growth, and continuous improvement. Employees are supported through structured training programs, career development pathways, and leadership engagement.
Key Responsibilities
Develop, validate, and maintain high-quality SAS programming code to generate SDTM datasets, ADaM datasets, TLF outputs, and other statistical deliverables as per study specifications and statistical analysis plans.
Ensure accuracy, quality, and compliance of deliverables with ICH guidelines, internal SOPs, Work Instructions, and sponsor requirements.
Lead and oversee programming activities across multiple complex or global studies, ensuring on-time delivery of all assigned outputs.
Direct and mentor statistical programmers, monitor project progress, and provide technical guidance for advanced programming tasks.
Create detailed specifications for datasets and outputs, anticipating programming challenges and ensuring efficient development processes.
Maintain complete and inspection-ready documentation, including validation reports, QC documents, and programming specifications.
Coordinate and conduct internal meetings, distribute meeting materials, track action items, and maintain effective communication across project teams.
Review study documents including Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and database designs, providing proactive, improvement-oriented feedback.
Participate in sponsor discussions, bid defense meetings, and project kickoffs as the statistical programming representative.
Serve as a subject matter expert for CDISC standards, providing guidance, conducting compliance reviews, and contributing to the development of DEFINE.XML and regulatory submission packages.
Contribute to the development of programming tools, macros, SOPs, and internal guidelines to improve standardization and efficiency.
Support the training and development of junior programmers through structured mentoring, training sessions, and code reviews.
Stay updated on evolving industry standards and regulatory expectations, communicating changes to the Biometrics Department.
Perform additional duties as required to support organizational objectives.
Minimal travel may be required.
Required Experience
Undergraduate degree in statistics, computer science, life sciences, or a related field; equivalent programming experience may be considered in place of a degree.
Extensive experience in SAS programming within a clinical trial environment, with a proven track record of leading complex or global studies.
Strong expertise in SDTM, ADaM, TLF generation, and CDISC regulatory submission standards.
Experience guiding and mentoring statistical programmers in CDISC processes and clinical trial workflows.
Prior involvement in preparing datasets and documentation for regulatory submissions is preferred.
Excellent communication skills, with the ability to read, write, and speak English fluently.
Comprehensive understanding of clinical drug development processes, industry best practices, and electronic submission requirements.
Why Join Syneos Health
Global exposure across therapeutic areas and study models.
Continuous professional development through technical and leadership training.
Collaborative culture built on diversity, authenticity, and career progression.
Participation in impactful projects that support leading global pharmaceutical companies.
Additional Information
The responsibilities listed are not exhaustive and may be modified based on business needs. Equivalent combinations of education, experience, and skills may be considered. Syneos Health complies with global employment regulations, including reasonable accommodations under applicable disability laws. Nothing in this posting should be interpreted as an employment contract.
Role Summary
This role involves designing, implementing, and overseeing statistical programming processes that generate datasets, tables, listings, and figures used for clinical trial analysis and regulatory submissions. As a senior technical expert, the Principal Statistical Programmer provides leadership, contributes directly to project success, and ensures alignment with industry and CDISC standards. The position has measurable impact on multiple functional areas and supports complex initiatives across the Biometrics organization.
Gujarat :
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Siliguri |Illinois :
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