Principal Statistical Programmer (SDTM, ADaM & TLF) – Remote, India
Location: Remote (India)
Employment Type: Full-Time
Job ID: 25104967
Experience Required: 8+ Years
Industry: Biopharmaceuticals | Clinical Research | Statistical Programming
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and commercial success. By combining deep expertise in clinical development, medical affairs, and data analytics, we deliver innovative solutions that support modern regulatory and business requirements.
With over 29,000 employees in 110+ countries, our mission is to simplify drug development, improve patient outcomes, and enable our teams to perform at their best. Our culture encourages collaboration, innovation, and professional growth in a fast-paced, patient-focused environment.
Role Overview
Syneos Health is seeking an experienced Principal Statistical Programmer with expertise in SDTM, ADaM, and TLF programming to join our global clinical programming team. This senior-level role is responsible for designing, developing, and validating high-quality statistical programming outputs to support clinical trials and regulatory submissions.
The role combines technical expertise, leadership, and mentoring responsibilities for junior programmers, ensuring projects are delivered on time, compliant with CDISC standards, and aligned with sponsor expectations.
Key Responsibilities
Develop and validate statistical programming code using SAS or equivalent software to generate summary tables, listings, figures, and derived datasets per Statistical Analysis Plan (SAP) and programming specifications
Lead programming activities for multiple concurrent projects, ensuring outputs meet quality standards and regulatory requirements
Create specifications for datasets and outputs, anticipating programming challenges and optimizing workflow efficiency
Conduct quality control, review project documentation (SAPs, mock shells, programming specs, annotated CRFs), and provide actionable feedback
Participate in internal and sponsor meetings, including study kick-offs, status updates, and bid defense presentations
Mentor and train junior statistical programmers; provide guidance on CDISC standards, SDTM, ADaM, and regulatory requirements
Maintain comprehensive project documentation for inspection readiness and audit compliance
Collaborate with biostatisticians, data managers, and cross-functional teams to resolve discrepancies and ensure accuracy of outputs
Contribute to the development of programming tools, macros, and SOPs for standardization and efficiency
Ensure timely delivery of programming deliverables, negotiate timelines, and implement risk mitigation strategies as needed
Stay current with industry standards, regulatory guidance, and CDISC updates to support compliant programming practices
Perform additional duties and projects as assigned; minimal travel may be required (<25%)
Required Qualifications
8+ years of experience in clinical SAS programming or statistical programming in a CRO or biopharmaceutical setting
Strong expertise in Base SAS, SAS Macros, SDTM, ADaM, and TLF creation
Hands-on experience with safety and efficacy clinical trial data
Experience with ISS/ISE submissions and R programming preferred
Familiarity with oncology therapeutic areas is a plus
Proven ability to mentor and lead junior programming staff
Excellent English communication skills, both written and verbal
Strong organizational skills with the ability to manage multiple priorities and meet strict deadlines
Immediate joiners preferred
Why Join Syneos Health
Work with a global leader in clinical research supporting FDA- and EMA-approved products
Contribute to innovative, high-impact clinical programs
Opportunity to grow professionally in a mentorship-driven, collaborative environment
Inclusive culture that values diversity, equity, and authentic contribution
Exposure to advanced statistical programming tools and regulatory standards
Equal Opportunity Statement
Syneos Health is an equal opportunity employer. Qualified applicants will be considered without regard to race, gender, disability, or background. Transferable skills and equivalent experience may be considered. Reasonable accommodations will be provided as required by applicable law.
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