5 дней назад
Manager of Statistical Programming (Oncology)
132 000 - 165 350$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager of Statistical Programming (R/Oncology): Leading statistical programming deliverables and clinical trial analysis for oncology diagnostic regulatory submissions with an accent on R package development, analysis datasets, and TLF generation. Focus on building R Shiny dashboards, validating controlled statistical computing environments, and ensuring compliance with ICH, GCP, and FDA 21 CFR Part 11.
Location: US Remote
Salary: $132,000–$165,350 USD per year
Company
develops cfDNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.
What you will do
- Lead statistical programming deliverables, including analysis datasets and tables, listings, and figures.
- Serve as the primary programming lead for 510(k), CTA/CDx, and PMA regulatory submissions.
- Manage and develop statistical programmers while contributing hands-on to programming work.
- Develop, validate, and maintain R packages and controlled statistical computing infrastructure.
- Build R Shiny dashboards for data review, study monitoring, and analysis-result exploration.
- Collaborate with Biostatistics, Data Management, Clinical Science, and other functions.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field.
- 5+ years of related experience, including at least 3 years in clinical trial analysis.
- At least 3 years of R programming experience, including package development.
- Experience generating analysis datasets and tables, listings, and figures.
- Knowledge of ICH, GCP, FDA 21 CFR Part 11, and regulatory submission standards.
- Must be based in the United States for this remote role.
Nice to have
- Experience with NGS, genetics, and/or oncology diagnostics.
- Experience maintaining statistical computing environments.
Culture & Benefits
- Cross-functional work with statisticians, geneticists, doctors, laboratory scientists, software engineers, and other specialists.
- Medical, dental, vision, life, and disability plans for eligible employees and dependents.
- Fertility care benefits and free testing for employees and immediate family members.
- Pregnancy and baby bonding leave, 401(k) benefits, commuter benefits, and an employee referral program.
- Inclusive workplace committed to diverse backgrounds, experiences, abilities, and perspectives.
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