Principal Statistical Programmer – Clinical Data Analysis (Pune)
Job Summary
Syneos Health is seeking a Principal Statistical Programmer to lead and execute high-impact statistical programming tasks in support of global clinical trials. Based in Pune, this senior-level role demands extensive experience (typically 8+ years) in clinical data programming, statistical methods, and SAS/R/Python development. You’ll lead cross-functional projects and mentor junior team members while ensuring compliance with ICH and FDA/EMA regulatory standards.
This opportunity is ideal for professionals looking to influence complex trial designs and statistical deliverables in a high-performing pharma CRO environment.
Key Responsibilities
Develop, validate, and maintain advanced statistical programs for CDISC-compliant datasets (SDTM, ADaM), TLFs, and other outputs.
Collaborate closely with biostatisticians, clinical teams, and data managers to ensure the accuracy of statistical deliverables.
Serve as a technical SME and mentor to junior statistical programmers.
Perform code reviews, ensure data integrity, and maintain consistency with regulatory requirements.
Contribute to process improvements and programming standards across clinical trial programming functions.
Participate in project planning, timelines, and risk mitigation strategies.
Stay abreast of the latest programming technologies and statistical methods relevant to clinical research.
Required Skills & Qualifications
Minimum 8+ years of statistical programming experience in the clinical research or pharmaceutical industry.
Master’s or Bachelor’s degree in Statistics, Computer Science, Life Sciences, or related field.
Expert in SAS programming; proficiency with R or Python is a strong advantage.
Proven experience with CDISC standards (SDTM, ADaM) and TLF generation.
SAS Certification (e.g., SAS Certified Advanced Programmer) is preferred.
Strong understanding of FDA, EMA, ICH-GCP guidelines, and regulatory compliance in clinical trials.
Excellent problem-solving, data interpretation, and analytical skills.
Strong written and verbal communication abilities with team collaboration mindset.
Perks & Benefits
Opportunity to contribute to global clinical trials and new drug approvals.
Continuous technical training and upskilling support in statistical programming.
Flexible work culture promoting inclusion and growth.
Access to global experts and cross-functional collaboration.
Competitive compensation with recognition programs.
Company Description
Syneos Health® is a top-tier biopharmaceutical solutions provider, having supported over 94% of novel FDA approvals in recent years. With 29,000 employees across 110 countries, the company integrates clinical, medical, and commercial expertise to accelerate drug development and improve patient outcomes globally.
Work Mode
On-site – Pune, India
Call to Action
Advance your career in clinical data science with a global CRO leader.
Apply now for the Principal Statistical Programmer role at Syneos Health and play a key role in advancing life-changing therapies.
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