Associate Director, Statistical Programming

Definium Therapeutics

. Provide statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization .

Posted 9/24/2026full-timeRemote • United StatesSenior💰 $155,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in statistical programming and data standards, with a strong focus on SAS programming, regulatory compliance, and collaboration with cross-functional teams in clinical trial settings.

Highest-signal resume keywords

SAS ProgrammingStatistical Programming SupportCDISC StandardsPinnacle 21 ValidationProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisData ValidationDefine XML PackagesPROC FreqPROC REPORTPROC GLMPROC MIXEDData StandardsClinical Trial Data ReviewQC Validation

Soft Skills

Organizational SkillsInterpersonal SkillsTeam CollaborationDetail-OrientedEffective Communication

Certifications & Qualifications

Master's Degree in BiostatisticsMaster's Degree in StatisticsMaster's Degree in Computer Science

Industry Keywords

Clinical TrialsRegulatory FilingCNS Clinical TrialsData ManagementStatistical Analysis Plans

About the role

Key responsibilities & impact

Provide statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization
Serve as study lead programmer for assigned clinical trials
Collaborate with study statisticians, data management, and other study team functions
Review and ensure quality of Define packages, including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and Define XML
Review Define packages for integrated datasets to ensure CDISC standards and regulatory submission requirements
Work with the study lead biostatistician to manage vendor deliverables for quality and timelines
Perform independent QC validation of vendor deliverables, datasets, and analytical outputs
Validate analytical outputs produced by internal biostatisticians or statistical programmers
Produce systematic data reports with Clinical Data Management to support clinical trial data review and cleaning
Review CRFs and/or Data Transfer Specifications to ensure data collection meets study objectives, requirements, and CDISC standards
Provide input to Statistical Analysis Plans and TLF shells for Tables, Listings, and Figures
Perform statistical analyses supporting publications and regulatory correspondence
Perform other assigned duties

Requirements

What you’ll need

Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields
At least 12 years of experience providing statistical programming support in a clinical trial setting
Deep understanding of data standards
Rich experience understanding Pinnacle 21 validation reports and creating Define XML packages to support regulatory filing
Proficiency in SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures such as PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED
Demonstrated capacity to collaborate with biostatisticians, Clinical Data Management, and colleagues from other functions
Strong organizational and project management skills
Proven ability to work on multiple projects in a fast-paced environment
Detail-oriented with high standards of excellence for Statistical Programming deliverables
Ability to deliver and communicate effectively in a work-from-home environment
Excellent interpersonal skills and ability to be a good team player
Preferred: experience in data structure and data analysis in CNS clinical trials
Preferred: experience providing integrated data analysis support in regulatory filing

Benefits

Comp & perks

100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave
Some fun fringe perks
Additional compensation, including bonus and equity may be available