About this role
Senior Statistical Analyst - Programmer performs statistical programming for AbbVie-sponsored Phase I-IV clinical studies, integrated summaries, and regulatory responses. The role may also serve as a study lead, overseeing programming tasks and ensuring deliverable quality and timelines.
Key Responsibilities
- Leads statistical programming and documentation support for multiple studies
- Reviews statistical analysis plans with program lead and provides comments
- Creates ADaM data set specifications and ADaM data sets
- Ensures analysis consistency with standard templates and specifications
- Conducts high-level review of CRO/FSP deliverables for quality and accuracy
Technical Overview
Hands-on SAS-based statistical programming for clinical trials, including creation of ADaM data set specifications, review of statistical analysis plans, and ensuring CDISC compliance. Supports regulatory filing submissions and performs high-level review of CRO/FSP deliverables for quality and accuracy.
Ideal Candidate
The ideal candidate is a senior-level statistical programmer with 6+ years (MS) or 8+ years (BS) of experience in SAS programming for drug development across Phase I-IV clinical studies. They have strong CDISC (CDISC Standards) experience, including creating and reviewing ADaM data set specifications, and they’ve supported regulatory filings and submission activities.
Must-Have Skills
Degree in StatisticsMathematicsor Engineering6+ years of relevant experience (with MS) OR 8+ years of relevant experience (with BS)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 StandardsFundamental understanding of the drug development processAbility to communicate clearly both oral and writtenAbility to accurately estimate effort required for study related programming activities
Required Skills
SAS programmingstatistical programmingPhase I-IV clinical studiesstatistical analysis plansADaM data set specificationsCDISC standardsregulatory filingsintegrated summariessubmission supportCROsFSPsdrug development processeffort estimation
Hard Skills
SAS programmingSAS programming conceptsSAS programming techniquesstatistical programmingPhase I-IV clinical studiesstatistical analysis plansADaM data set specificationsADaM specificationsADaM data setsintegrated summariesregulatory filingsCDISC standardsCDISC Standardshigh level reviewprogramming documentationCROsFSPsdata managementmedical writingregulatory publishingclinical operationsstudy timeline managementeffort estimation
Soft Skills
clear oral communicationclear written communicationhigh quality workcommunicationcoordinationgood communication with cross-functional teamsaccurate effort estimationprocess improvement initiative participation
Keywords for Your Resume
Senior Statistical AnalystSenior Statistical Analyst - ProgrammerStatistical AnalystStatistical programmingSAS programmingSAS programming conceptsSAS programming techniquesPhase I-IV clinical studiesstatistical analysis plansADaM data set specificationsADaMintegrated summariesCDISC standardsCDISC Standardsregulatory filingssubmission supporturgent regulatory agency requestsCROsFSPsCROFSPdata managementmedical writingregulatory publishingclinical operationseffort requiredstudy leadprogramming documentation supportstatistical programmingdrug development process
Deal Breakers
Must have experience with SAS programming related to drug development, Must have experience with regulatory filings, Must have experience adhering to CDISC standards and creating and reviewing ADaM specifications, Must meet the stated degree and experience requirement (Statistics/Math/Engineering; 6+ years with MS or 8+ years with BS)
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