12 дней назад
Associate Director Statistical Programming - Pharmacometrics (SAS)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director Statistical Programming - Pharmacometrics (SAS): Leading programming, quality control, and integration of clinical-trial analysis datasets and tables, listings, and figures for pharmacometrics programs with an accent on SAS-based clinical data programming, CDISC standards, and pharmacokinetic analysis. Focus on coordinating multi-project deliverables, validating electronic submissions, integrating Exposure-response, PopPK, and PopPKPD data, and mentoring programming staff.
Location: Four days onsite per week in Tarrytown, New York, or Warren, New Jersey, United States
Company
is a biotechnology company that develops and commercializes medicines for serious diseases.
What you will do
- Lead programming and quality control for analysis datasets, tables, listings, and figures across multiple clinical studies and projects.
- Coordinate pharmacometrics programming activities, data exchanges, deliverables, timelines, and cross-functional collaboration.
- Create, manage, and maintain programming specifications using data models, tools, and methodologies.
- Integrate data across studies to support Exposure-response, PopPK, PopPKPD, clinical pharmacology, publications, and regulatory reporting.
- Lead the creation and validation of electronic submission materials, including annotated CRFs, data export files, and define documents.
- Plan resources, milestones, validation activities, and project requirements while mentoring junior programming staff.
Requirements
- Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline.
- 10+ years of programming experience, preferably processing clinical-trial data in the biotechnology, pharmaceutical, or healthcare industry.
- Expert SAS programming skills, including Base, Stat, Macro, and graph capabilities, in a clinical data environment.
- Knowledge of relational database structures, reporting systems, data handling, biostatistics, clinical development, pharmacokinetics, immunogenicity, and Exposure-response analysis.
- Experience with standardization methodologies and current CDISC data standards.
- Ability to work onsite four days per week in Tarrytown, NY, or Warren, NJ.
Nice to have
- Experience in project and people management and expertise in one or more therapeutic areas.
- SAS certification in statistics or computer science.
- Experience with R programming, Python, SAS Studio, Microsoft Excel, and AI use cases in statistical programming and data science.
Culture & Benefits
- Multidisciplinary collaboration supporting clinical trials through regulatory approval, product launch, and annual reporting.
- Inclusive workplace and equal-opportunity employment environment.
- Comprehensive rewards may include bonuses, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
- Reasonable accommodations are available during the recruitment process where required.
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