Principal Stat Programmer

0-2 years
Not Disclosed
10 March 31, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 


Principal Statistical Programmer

Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002564

About Syneos Health

Syneos Health® is a leading biopharmaceutical solutions organization committed to accelerating clinical development. We integrate clinical, medical affairs, and commercial insights to deliver innovative solutions that bring therapies to market faster.

Job Overview

As a Principal Statistical Programmer, you will play a critical role in developing and validating statistical programming code using SAS and other software. You will support clinical trial data analysis, ensuring compliance with industry standards and regulatory requirements. This position involves leading multiple projects, mentoring junior programmers, and collaborating cross-functionally with clinical research teams.

Key Responsibilities

  • Develop custom SAS programming to generate data listings, tables, graphs, and derived datasets.

  • Ensure high-quality statistical outputs aligned with project requirements.

  • Perform validation programming and resolve data discrepancies.

  • Maintain compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH-GCP, FDA, EMA).

  • Act as the lead statistical programmer, overseeing project timelines and deliverables.

  • Mentor and train junior programmers on clinical trial processes and programming best practices.

  • Participate in sponsor meetings, audits, and regulatory submissions.

  • Manage documentation and compliance, ensuring all project files are inspection-ready.

Qualifications & Skills

  • Bachelor’s degree in Statistics, Computer Science, Life Sciences, or a related field.

  • Extensive experience in SAS programming for clinical trials.

  • Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements.

  • Proven ability to lead multiple global projects and manage timelines.

  • Excellent problem-solving, time management, and communication skills.

  • Ability to collaborate in a cross-functional team environment.

Why Join Syneos Health?

  • Work with 94% of FDA-approved drugs in the past five years.

  • Gain global exposure in clinical research.

  • Career growth opportunities with mentorship and professional development.

  • Inclusive and dynamic work culture that values innovation and teamwork.