✦ Luna Orbit — Data & Analytics

Senior Statistical Analyst - Programmer (Hybrid)

at AbbVie

📍 North Chicago, IL Hybrid Posted April 15, 2026
Apply Now → ← Browse All Jobs

Position Details

Type Full-Time
Experience senior
Exp. Years 6+ years of relevant experience (with MS) OR 8+ years (with BS)
Education Degree in Statistics, Mathematics, or Engineering
Category Data & Analytics

About this role

Senior Statistical Analyst - Programmer supporting statistical programming for AbbVie-sponsored Phase I-IV clinical studies and integrated summaries. The role includes submission support, regulatory agency response support, and can serve as a study lead while overseeing programming work quality from CRO/FSP teams.

Key Responsibilities

  • Lead statistical programming activities for multiple studies
  • Create ADaM data set specifications and ensure study consistency with templates
  • Review statistical analysis plans and provide comments to study biostatistician
  • Support submissions and urgent regulatory agency requests
  • Oversee and perform high level review of CRO/FSP deliverables

Technical Overview

Primary focus is SAS-based statistical programming for clinical trial deliverables, including creation of ADaM data set specifications and ensuring consistency with CDISC standards and standard templates. The role performs high-level review of CRO/FSP deliverables and contributes to documentation, statistical analysis plan (SAP) review, and urgent regulatory requests.

Ideal Candidate

The ideal candidate is a senior statistical programmer/analyst with 6+ years of relevant experience (or 8+ with a BS) performing statistical programming for Phase I-IV clinical studies. They are highly proficient in SAS programming for drug development, have strong experience with regulatory filings, and understand CDISC standards with hands-on creation/review of ADaM data set specifications. They can lead study programming activities, review deliverables from CRO/FSP teams, and communicate clearly with cross-functional partners.

Must-Have Skills

Experience with SAS programming related to drug developmentExperience with regulatory filingsExperience adhering to CDISC standards and creating and reviewing ADaM speicificationsIn-depth understanding of SAS programming concepts and techniques related to drug developmentFundamental understanding of CDISC StandardsAbility to communicate clearly both oral and writtenAbility to accurately estimate effort required for study related programming activities

Nice-to-Have Skills

Knowledge of R or Ai (as written: Ai)

Tools & Platforms

SAS

Required Skills

statistical programmingSAS programmingregulatory filingsCDISC standardsADaM data set specificationscreating and reviewing ADaM specificationsstatistical analysis plan reviewPhase I-IV clinical studiesintegrated summarieseffort estimationCRO coordinationFSP coordinationdata managementmedical writingregulatory publishingclinical operations

Hard Skills

statistical programmingPhase I-IV clinical studiesintegrated summariesregulatory filingsADaM data set specificationsADaMSAS programmingSASCDISC standardsCDISCcreating and reviewing ADaM specificationsreviewing statistical analysis plansdata set specificationsstudy analysis consistency with standard templates and specificationssupport urgent regulatory agency requestsprogramming documentation supportprogram lead collaborationCROsFSPsdata managementmedical writingregulatory publishingclinical operationshigh level review of deliverablestime estimation for study programming activitiesprogramming tasks for a single studyeffort estimation

Soft Skills

communication clearly both oral and writtenleadershipprovide programming and documentation support for multiple studiesgood communication with CROs/FSPs and internal teamscoordinate own task assignmentsensure good communication and timelines

Industry & Role

Industry Healthcare
Job Function Provide SAS statistical programming leadership for compliant, high-quality clinical trial deliverables.
Role Subtype Data Analyst
Tech Domains Python

Keywords for Your Resume

Senior Statistical AnalystStatistical Analyst - ProgrammerSAS programmingSASstatistical programmingPhase I-IV clinical studiesintegrated summariesregulatory filingsCDISC standardsCDISCADaMADaM data set specificationscreating and reviewing ADaM specificationsstatistical analysis plandata set specificationsCROFSPdata managementmedical writingregulatory publishingclinical operationsprogramming deliverablesstudy leadprogram leadeffort estimationurgent regulatory agency requestsSAS programming conceptsCRO/FSP

Deal Breakers

Experience with SAS programming related to drug development, Experience with regulatory filings, Experience adhering to CDISC standards and creating and reviewing ADaM specifications, Degree in Statistics, Mathematics, or Engineering

Apply for this Position →

Get matched to jobs like this

Luna finds roles that fit your skills and career goals — no endless scrolling required.

Create a Free Profile