Job Title:
Senior Principal Statistical Programmer
Updated: October 23, 2025
Location: India – Remote
Job ID: 25102468
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By integrating clinical, medical affairs, and commercial insights, we deliver outcomes that meet modern healthcare and market needs.
Our Clinical Development model places the customer and patient at the center of everything we do. We constantly innovate to simplify operations, streamline workflows, and enhance collaboration — making Syneos Health both easier to work with and easier to work for.
With 29,000 employees across 110 countries, we bring a unique combination of agility, expertise, and passion to transform patient outcomes.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
Focused on career growth, progression, and technical skill development.
Supportive and engaged line management with ongoing recognition and rewards programs.
Commitment to a “Total Self” culture – promoting authenticity, inclusion, and well-being.
A diverse, global workforce fostering belonging, collaboration, and innovation.
Dedicated to creating an environment where every individual’s contribution matters.
Role Overview
The Senior Principal Statistical Programmer plays a leadership role in planning, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions. This position combines technical expertise in programming (primarily SAS) with a strong understanding of clinical data standards, study design, and regulatory expectations.
The individual is expected to provide strategic programming guidance, lead multiple project teams, ensure data integrity, and uphold quality and compliance standards across global clinical studies.
Key Responsibilities
Lead and oversee statistical programming activities for complex clinical studies or across multiple projects.
Design, develop, and validate datasets, tables, listings, and figures (TLFs) according to CDISC standards (SDTM, ADaM).
Collaborate closely with biostatisticians, data managers, and clinical teams to ensure seamless data flow and analysis readiness.
Drive automation and standardization initiatives to enhance programming efficiency.
Provide technical leadership, mentorship, and training to junior programmers.
Ensure all deliverables meet quality, regulatory, and timeline expectations.
Participate in the development of programming standards, tools, and best practices.
Conduct peer reviews, QC checks, and ensure adherence to SOPs and guidelines.
Contribute to regulatory submissions, including integrated summaries and ad-hoc requests.
Serve as a subject matter expert (SME) on statistical programming methodologies, processes, and technologies.
Key Skills & Competencies
Expertise in SAS Programming and clinical data standards (CDISC SDTM, ADaM).
Strong understanding of clinical trial design, data management, and statistical analysis principles.
Experience in regulatory submission programming (FDA/EMA).
Proven ability to lead project teams, manage timelines, and ensure quality deliverables.
Excellent communication, documentation, and problem-solving skills.
Knowledge of automation tools, macros, and version control systems (e.g., Git, JIRA) preferred.
Impact & Contribution
The Senior Principal Statistical Programmer ensures the accuracy and reliability of statistical outputs that support regulatory decisions and clinical insights. By maintaining high-quality programming standards and leading cross-functional collaboration, this role contributes directly to the successful and timely delivery of clinical trials and the advancement of new therapies to patients.
About Syneos Health – Quick Facts
Partnered in 94% of all FDA-approved novel drugs in the past 5 years.
Contributed to 95% of EMA-authorized products.
Supported 200+ studies across 73,000 sites and 675,000+ trial patients globally.
Learn more: www.syneoshealth.com
Additional Information
Responsibilities listed are not exhaustive; additional duties may be assigned.
Equivalent combinations of experience, education, and skills will be considered.
Syneos Health is committed to equal opportunity employment and reasonable accommodations under the Americans with Disabilities Act (ADA).
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