Senior Principal Statistical Programmer

Syneos Health

8-12 years

Not Disclosed

Remote

10 Nov. 5, 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

Position: Senior Principal Statistical Programmer

Updated: October 23, 2025
Location: IND – Remote
Job ID: 25102468
Company: Syneos Health®

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company combines clinical, medical affairs, and commercial expertise to deliver outcomes that meet evolving market needs.

With a patient- and customer-centered approach, Syneos Health continuously simplifies and enhances clinical development to make processes easier, faster, and more efficient — for both partners and employees.

WORK HERE MATTERS EVERYWHERE

Why Join Syneos Health

Career growth & progression through continuous learning and development.
Supportive leadership and engaged line management.
Access to technical, statistical, and therapeutic area training.
Recognition through peer rewards and total rewards programs.
A Total Self Culture that promotes authenticity and inclusion.
A workplace committed to diversity, belonging, and collaboration.

Role Overview

The Senior Principal Statistical Programmer plays a leadership role in biostatistics and programming for clinical trials.
This role is responsible for planning, developing, validating, and delivering statistical programming outputs, ensuring compliance with industry standards (CDISC SDTM, ADaM) and regulatory expectations.

The position requires advanced technical expertise, strategic thinking, and leadership in programming activities across multiple projects or therapeutic areas.

Key Responsibilities

Lead statistical programming activities for complex clinical trials and integrated submissions (e.g., ISS/ISE).
Design and implement statistical programming strategies, including dataset creation, analysis, and validation.
Develop, validate, and maintain SDTM and ADaM datasets per CDISC and regulatory requirements.
Create TLFs (Tables, Listings, and Figures) for clinical study reports, regulatory submissions, and ad-hoc requests.
Provide technical oversight, mentorship, and support to junior programmers and project teams.
Collaborate cross-functionally with biostatisticians, data managers, and clinical teams to ensure accuracy and consistency in deliverables.
Develop and maintain SAS macros, tools, and utilities to improve efficiency and standardization.
Participate in regulatory submissions and data standards governance initiatives.
Ensure deliverables meet quality, accuracy, and compliance standards (e.g., FDA, EMA, CDISC, GCP).
Contribute to best practices and process improvements within the programming department.

Key Skills & Competencies

Expertise in SAS programming and CDISC standards (SDTM, ADaM).
Strong understanding of clinical data structures and statistical concepts.
Proven experience with clinical trial reporting and regulatory submission deliverables.
Advanced proficiency in statistical programming, validation, and quality control.
Excellent leadership, mentoring, and project management abilities.
Strong communication and collaboration skills across global teams.
Ability to manage multiple priorities under tight timelines with minimal supervision.

Education & Experience Requirements

Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
8–12 years of experience in statistical programming within the clinical research or pharmaceutical industry.
Hands-on experience in regulatory submissions (NDA/BLA/MAA) and integrated analyses.
Deep understanding of CDISC data standards, GCP, and regulatory guidelines.
Proficiency with SAS, R, or similar statistical software.

About Syneos Health (Quick Facts)

Partnered with 94% of all FDA-approved novel drugs in the past 5 years.
Supported 95% of EMA-authorized products.
Delivered 200+ studies across 73,000 sites with 675,000+ trial participants globally.

Learn more: www.syneoshealth.com

Additional Information

Responsibilities described are not exhaustive; other tasks may be assigned as needed.
Equivalent education or experience will be considered where applicable.
Syneos Health adheres to all global equal opportunity and ADA compliance standards.
The company fosters a diverse, inclusive, and authentic work environment — encouraging candidates with transferable skills to apply.

Join Us

If you’re passionate about clinical data science, innovation, and leading impactful statistical programming initiatives,
Apply Now or Join Our Talent Network to stay updated on future career opportunities at Syneos Health.

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Senior Principal Statistical Programmer

Job Description

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