Associate Director, Statistical Programming

Vividion Therapeutics. Inc.

. Provide comprehensive statistical programming leadership and support to clinical project teams .

Posted 10/27/2026full-timeSan Diego • California • United StatesSenior💰 $180,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in statistical programming and regulatory compliance, with a strong focus on SAS programming for clinical trials, including SDTM and ADaM datasets. Proven ability to lead programming activities, enhance processes, and collaborate effectively with cross-functional teams.

Highest-signal resume keywords

SAS ProgrammingCDISC StandardsStatistical Analysis PlansClinical Trial MethodologyRegulatory Compliance

ATS Keywords

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Hard Skills

Statistical ProgrammingData AnalysisProgramming SpecificationsClinical Data StructureDrug Development ProcessRelational DatabasesADaM SpecificationsTFL DevelopmentXML ProcessingE-Submission Components

Soft Skills

Team CollaborationProactive CommunicationProblem Solving

Tools & Technologies

MS OfficePinnacle 21

Industry Keywords

BiostatisticsClinical OperationsRegulatory GuidanceMedical TerminologyClinical Project Teams

About the role

Key responsibilities & impact

Provide comprehensive statistical programming leadership and support to clinical project teams
Deploy programming strategies, standards, specifications, and programmed analyses compliant with regulatory requirements, SOPs, and work practices
Oversee CRO SAS programming activities and progress to ensure timely, high-quality project delivery
Oversee CRO efforts related to derived datasets, programs, and analysis dataset specifications
Oversee development of SAS programs for SDTM and ADaM datasets following CDISC standards
Oversee development of SAS programs for Tables, Listings, and Figures for clinical trials
Lead statistical programming activities across multiple studies or a compound
Lead and support electronic submission preparation and review
Review statistical analysis plans, mock shells, data review plans, and related programming assumptions and requirements
Independently develop, validate, troubleshoot, and maintain complex programs and utilities
Develop robust programming specifications, including ADaM specifications
Communicate issues and risks proactively and contribute to remediation
Identify, lead, and support opportunities to enhance processes and technology
Work closely with the Biometrics Team, Clinical Operations, Regulatory, related disciplines, and CROs
Report to the Director, Biostatistics

Requirements

What you’ll need

Bachelor’s or MS degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 8 years programming experience in industry, including support of significant regulatory filings
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
Broad expertise in statistical programming and developing computing strategies
In-depth understanding of clinical data structure, including CDISC standards, and relational databases
Demonstrated proficiency using SAS to produce analysis datasets and TFLs
Experience using MS Office, XML, and Pinnacle 21
Demonstrated ability processing upstream data, including multiple data forms, workflows, eDC, and SDTM
Demonstrated ability providing downstream deliverables, including ADaM, TFLs, and e-submission components
Demonstrated ability to work in a team environment with clinical team members

Benefits

Comp & perks

Target bonus
Long-term incentives
401k retirement savings plan with company match
Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
Opportunities for mentorship and career progression