Instagram
youtube
Facebook

Principal Statistical Programmer - Sponsor Dedicated

5+ years
Not Disclosed
10 Sept. 23, 2025
Job Description
Job Type: Full Time Hybrid Remote 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: Principal Statistical Programmer – Sponsor Dedicated
Location: 21 Locations (100% home-based in EMEA or local office in home country)
Category: Clinical
Job ID: 253606


Job Overview

The Principal Statistical Programmer plays a critical role in delivering complex clinical projects for a leading global pharmaceutical sponsor. This role involves planning, executing, and overseeing programming activities, liaising with cross-functional teams, mentoring junior programmers, supporting submissions, and ensuring high-quality outputs aligned with regulatory and sponsor standards.


Key Responsibilities

Programming Oversight

  • Plan, execute, and oversee all statistical programming activities for assigned studies.

  • Manage resources, work within budget, meet timelines, and maximize quality.

  • Oversee SDTM, ADaM, and TLF development and perform senior-level review of outputs.

Cross-Functional Collaboration

  • Liaise with Clinical, Medical Writing, Safety, and Biometrics teams.

  • Coordinate additional programming support for publications, medical writing, and analyses.

  • Support and oversee submission activities, particularly in late-phase studies.

Quality & Process Management

  • Ensure efficient execution of programming tasks with proper tools and macros.

  • Prioritize quality while adhering to departmental standards and processes.

Mentorship & Training

  • Mentor less-experienced team members on SDTM, ADaM, and TFL best practices.

  • Promote adherence to programming standards and departmental processes.


Required Qualifications & Experience

  • Degree in Mathematics, Life Sciences, Statistics, Computer Science, or equivalent professional experience in statistical programming within clinical trials.

  • Minimum 5 years of experience with complex clinical trials, including understanding of safety and efficacy datasets and endpoints.

  • Knowledge of end-to-end clinical trial processes, including roles of Biostatistics and Clinical Data Management.

  • Expert knowledge of base SAS, SAS macros, SAS/STAT, and debugging SAS programs.

  • Broad understanding of CDISC standards (SDTM, ADaM), define.xml, Reviewer's Guides, and submission requirements.

  • Fluency in English, both verbal and written.

  • Autonomous, collaborative, detail-oriented, and curious mindset.


Preferred Qualifications

  • Experience supporting regulatory submissions and publications.

  • Exposure to multi-therapeutic area studies.

  • Leadership experience in guiding junior programmers and cross-functional teams.


Work Environment

  • Home-based or office-based in EMEA.

  • Collaborative global CRO environment with opportunities for career growth.