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Sr Statistical Programmer(Pk/Pd)

5+ years
Not Disclosed
10 March 9, 2025
Job Description
Job Type: Full Time 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: Senior Statistical Programmer (PK/PD)

Location: India (Home-Based)

Company: Syneos Health

Job ID: 25002086

Updated On: March 5, 2025

Job Overview:

The Senior Statistical Programmer (PK/PD) is responsible for developing custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets. This role involves working closely with biostatisticians and project team members to ensure quality and compliance with regulatory standards.

Key Responsibilities:

  • Develop SAS programming to generate statistical outputs per the statistical analysis plan.
  • Perform validation programming and resolve discrepancies.
  • Ensure outputs meet quality and regulatory requirements.
  • Maintain project documentation and ensure inspection readiness.
  • Manage multiple projects and adapt to timeline changes.
  • Prepare and review specifications for datasets and outputs.
  • Conduct internal meetings and communicate updates to stakeholders.
  • Act as a lead programmer, directing other team members.
  • Participate in sponsor meetings and bid defenses.
  • Mentor and train junior programmers.

Qualifications:

  • Undergraduate degree in a scientific or statistical discipline (or equivalent experience in R & SAS programming).
  • 5+ years of experience in Clinical SAS Programming, including SDTM, ADaM, and TLF generation.
  • Experience in PK/PD studies, NAC, Non-MEM, and Modeller.
  • Strong written and verbal communication skills.

Additional Information:

  • Minimal travel required.
  • Role involves compliance with global regulatory requirements.