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Principal Stat Programmer (Adam + Tfl)

0-2 years
Not Disclosed
10 May 1, 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

 

Job Title: Principal Statistical Programmer (ADaM + TFL)

Updated: April 22, 2025
Location: India (Home-Based, Asia-Pacific)
Job ID: 25002899
Company: Syneos Health


Position Summary

Syneos Health is seeking a Principal Statistical Programmer with over 5 years of experience in clinical research to lead and oversee programming activities, ensuring the delivery of high-quality statistical outputs in Phase 2 and Phase 3 studies. The role involves working with SAS and other statistical tools to generate summary tables, listings, graphs, and derived datasets, with a focus on meeting regulatory standards, timelines, and quality requirements. The ideal candidate will also serve as a mentor and technical expert, supporting the development of CDISC-compliant deliverables and driving programming efficiency across projects.


Key Responsibilities

  • Lead programming activities for complex, global clinical trials using SAS to generate statistical outputs (e.g., ADaM, TFLs, datasets).

  • Ensure compliance with regulatory requirements (e.g., CDISC, ICH) and maintain inspection readiness.

  • Provide programming expertise and technical leadership, overseeing the quality and accuracy of statistical analysis plans, programming specifications, and deliverables.

  • Mentor and guide junior statistical programmers, developing training materials and reviewing their work for quality and compliance.

  • Collaborate with biostatisticians, regulatory affairs, and other departments to ensure the timely and accurate delivery of project outputs.

  • Manage project timelines, deliverables, and risk mitigation strategies across multiple studies.

  • Contribute to the development and maintenance of programming tools, macros, and standard operating procedures (SOPs) for increased efficiency.

  • Participate in sponsor meetings, bid defense meetings, and provide technical guidance on the use of CDISC standards (e.g., SDTM, ADaM).

  • Act as a subject matter expert for CDISC standards, providing guidance and training to internal teams.

  • Review regulatory submission requirements and ensure compliance with industry standards for deliverables (e.g., DEFINE.XML).


Required Qualifications

  • Education: Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and programming experience).

  • Experience:

    • Extensive programming experience using SAS (or other required software) in clinical trials, including managing multiple complex projects.

    • Strong knowledge of CDISC Standards (SDTM, ADaM) and experience with regulatory submissions.

    • Proven ability to mentor and train junior programming staff and contribute to programming process improvements.

  • Skills:

    • Strong written and verbal communication skills.

    • Ability to work independently and collaboratively within a team.

    • In-depth knowledge of statistical programming and clinical drug development processes.


Why Join Syneos Health

  • Join a global leader working with 94% of FDA-approved novel drugs and 95% of EMA-authorized products.

  • Engage in diverse and innovative projects that change lives, working with a dynamic team across 110 countries.

  • Foster professional development through a supportive and engaging work environment that promotes continuous growth.