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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

 

Job Overview:

As a Principal Statistical Programmer, you'll develop custom programming using SAS or other statistical software to generate reports, analyze data, and support clinical trial submissions. You will work on multiple global projects, ensuring quality, compliance, and efficiency in data analysis and reporting.

Key Responsibilities:

  • Develop and validate statistical programs for clinical trials.

  • Generate reports, data tables, graphs, and listings as per study requirements.

  • Ensure data integrity and compliance with regulatory guidelines (ICH-GCP, CDISC, FDA).

  • Manage multiple projects and provide technical leadership to programming teams.

  • Act as a subject matter expert for CDISC standards and regulatory submissions.

  • Participate in sponsor meetings and audits.

  • Mentor and train junior programmers.

  • Collaborate with cross-functional teams including biostatisticians, data managers, and regulatory teams.

Qualifications & Skills:

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

  • Extensive experience in SAS programming within clinical trials.

  • Strong knowledge of CDISC standards (SDTM, ADaM).

  • Experience in regulatory submissions (FDA, EMA) is preferred.

  • Ability to lead projects and mentor junior team members.

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

  • Proficiency in clinical trial methodologies and database management.

Why Join Syneos Health?

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

  • Global exposure with cross-functional collaboration.

  • Opportunities for career growth and professional development.

  • Supportive and inclusive work culture.