Associate Director, Statistical Programming

🕒 September 24

🇺🇸 United States – Remote

💵 $155k - $195k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 4%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• 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

• 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

• 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