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Senior Statistical Programmer Fsp

6-8 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Full Time Hybrid 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

 

Senior Statistical Programmer – FSP
Location: United States (Hybrid – Preferred: PA or NJ)
Job Type: Full-Time
Department: Statistical Programming – FSP
Job ID: 647
Posting Date: April 10, 2025


Position Overview

This sponsor-dedicated hybrid role places you fully embedded within a global pharmaceutical client, working on cutting-edge clinical trials with support from Cytel. As a Senior Statistical Programmer, you will contribute to Early and Late-stage clinical studies, bringing innovation and scientific rigor to statistical programming and analysis in support of global regulatory submissions and scientific discoveries.


Key Responsibilities

  • Generate and validate statistical programming deliverables (SDTM, ADaM, TFLs).

  • Support Early Development Statistics and PK/PD Modeling across therapeutic areas.

  • Manipulate and analyze clinical trial data using SAS, focusing on both efficacy and safety.

  • Perform production, QC, and validation programming.

  • Generate complex ad-hoc reports from raw data.

  • Create and review submission documents and eCRTs.

  • Communicate project requirements, status, and issues with internal and client teams.

  • Lead projects or study teams as required.

  • Remain flexible and adaptable to evolving project priorities.


Qualifications

  • Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field.

  • Minimum 8 years of SAS programming experience in clinical trial data (6 years with a Master’s degree).

  • Experience in Early Development studies and pharmacokinetic data analysis.

  • Advanced SAS programming skills, especially with clinical endpoint data, ADaM, SDTM, and efficacy analysis.

  • Familiarity with submission standards (CDISC SDTM, ADaM, Define.XML, aCRF, SDRG).

  • Experience using Pinnacle 21 Enterprise and participating in up-versioning activities.

  • Strong QC/validation and ad-hoc reporting capabilities.

  • Familiarity with Oncology studies preferred.

  • Knowledge or experience in R, S-Plus, NonMem is a plus.

  • Ability to work in cross-cultural, globally dispersed teams and meet challenging deadlines.

  • Strong communication and problem-solving skills.


Preferred Work Location

  • Hybrid – Based in Pennsylvania (PA) or New Jersey (NJ) preferred

  • Remote support from Cambridge, MA or other U.S. locations may be considered