Senior Principal Statistical Programmer

10+ years

Not Disclosed

Remote

10 Oct. 28, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Senior Principal Statistical Programmer

Updated: October 23, 2025
Location: Remote – India
Job ID: 25102468

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We combine clinical, medical affairs, and commercial expertise to deliver results that meet modern healthcare challenges.

Our Clinical Development model places both the customer and the patient at the center of everything we do. We strive to simplify and optimize processes—making Syneos Health easier to work with and for.

With 29,000 employees across 110 countries, we collaborate as one global team of innovators, dedicated to transforming lives through science.

WORK HERE MATTERS EVERYWHERE.

Why Join Us

Continuous career development and growth opportunities.
Supportive leadership and engaged management.
Extensive technical and therapeutic area training.
Recognition through total rewards programs.
A global Total Self Culture—a workplace where you can truly be yourself.

We’re building an organization where diversity of thought, culture, and background drives innovation and where every voice is valued.

Role Summary

The Senior Principal Statistical Programmer is a senior technical leader responsible for providing statistical programming expertise to support clinical trials and regulatory submissions.
This role involves strategic planning, project oversight, and technical execution to ensure the delivery of high-quality programming outputs in compliance with CDISC, FDA, and ICH guidelines.

Key Responsibilities

1. Technical Leadership

Lead programming activities across multiple studies or therapeutic areas.
Provide expert-level SAS programming support for the creation, validation, and maintenance of SDTM, ADaM, and TFLs (Tables, Listings, Figures).
Ensure deliverables meet regulatory submission requirements (FDA, EMA, PMDA, etc.).
Review and validate statistical output for accuracy and compliance with data standards.

2. Project Management & Oversight

Serve as technical lead for assigned projects, ensuring timely delivery of quality outputs.
Develop programming timelines, resource estimates, and risk mitigation strategies.
Coordinate cross-functional activities with biostatistics, data management, and clinical teams.
Participate in client meetings and represent the programming function in audits and inspections.

3. Process & Quality Improvement

Drive process optimization and automation using macro libraries and R/SAS-based tools.
Contribute to standard operating procedures (SOPs) and process documentation.
Mentor and train junior programmers, promoting knowledge sharing and best practices.
Maintain adherence to internal quality control procedures and industry standards (CDISC, FDA/EMA submission requirements).

Qualifications & Experience

Education: Bachelor’s or Master’s in Statistics, Computer Science, Life Sciences, or related field.
Experience: Minimum 10+ years of hands-on experience in statistical programming within the pharmaceutical or CRO industry.
Strong proficiency in SAS (Base, Macro, SQL) and familiarity with R programming preferred.
Deep understanding of CDISC SDTM/ADaM standards, 21 CFR Part 11 compliance, and regulatory submission datasets.
Proven ability to lead global programming teams and manage complex, multi-study projects.
Excellent communication, documentation, and problem-solving skills.

Key Skills

SAS Programming (Advanced)
CDISC SDTM and ADaM Standards
Statistical Analysis & Reporting
Project and Team Leadership
Regulatory Submission Support
Quality Assurance & Validation
Cross-functional Collaboration

Impact & Contribution

The Senior Principal Statistical Programmer plays a pivotal role in ensuring data integrity, compliance, and timely delivery of clinical trial analyses.
By leading programming efforts across global studies, this role directly contributes to the success of regulatory submissions and the advancement of innovative therapies that change lives.

About Syneos Health’s Global Impact

Partnered with 94% of all Novel FDA-approved drugs over the last 5 years.
Supported 95% of EMA-authorized products.
Delivered over 200 studies across 73,000 sites and 675,000+ trial patients worldwide.

Learn more: 🌐 www.syneoshealth.com

Additional Information

Tasks and duties listed are not exhaustive and may evolve based on business needs.
Equivalent experience, education, or skills will be considered.
Syneos Health fully complies with the Americans with Disabilities Act (ADA) and EU Equality Directive.
Reasonable accommodations are available as needed.

How to Apply

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Senior Principal Statistical Programmer

Job Description

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