5 дней назад
Manager - Statistical Programming (Hybrid)
109 500 - 208 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager - Statistical Programming (Hybrid) (SAS/Pharmaceutical Development): Leading statistical programming for early-stage pharmaceutical compounds and therapeutic areas with an accent on team management, CDISC-compliant ADaM datasets, and Tables, Listings, and Figures. Focus on developing SAS programs and macros, coordinating cross-functional regulatory deliverables, and ensuring quality and consistency across clinical studies.
Location: Hybrid in Irvine, California, United States
Salary: $109,500–$208,500 USD per year
Company
develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead statistical programming activities for compounds, indications, or therapeutic areas in early pharmaceutical development.
- Manage statistical programmers, including resource planning, oversight, mentoring, and development.
- Develop and oversee SAS programs for CDISC-compliant ADaM datasets and Tables, Listings, and Figures.
- Ensure timely delivery, quality processes, and consistency across individual studies and integrated data.
- Prepare regulatory filing documentation, including reviewer guides and data definition documents.
- Lead the development of standard SAS macros and contribute to standard operating procedures.
Requirements
- Bachelor's degree in Statistics or Mathematics.
- 10+ years of relevant experience, or 8+ years with a master's degree.
- Previous experience leading a team or project of statistical programmers.
- Experience with SAS programming concepts and techniques used in drug development.
- In-depth understanding of CDISC standards, with required experience in ADaM development and TLF generation.
- Clear written and verbal communication and the ability to estimate programming effort accurately.
Nice to have
- Experience with regulatory filings.
Culture & Benefits
- Cross-functional collaboration with Statistics, Data Sciences, Medical Writing, Regulatory Publishing, and Clinical Operations.
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) and eligibility for long-term incentive programs.
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