4 дня назад
Biostatistics Associate Director (HYBRID)
174 800 - 262 200$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Biostatistics Associate Director (Biostatistics/Clinical Development): Leading statistical analyses for clinical trials, observational studies, and real-world data investigations with an accent on advanced statistical methods, study design, and regulatory support. Focus on authoring statistical analysis plans, guiding cross-functional teams, reviewing TFLs and programming specifications, and addressing complex drug development challenges using SAS and R.
Location: Boston, MA, United States. Hybrid-eligible with remote work up to two days per week, or on-site five days per week with ad hoc flexibility.
Salary: $174,800–$262,200 per year, plus annual bonus and equity awards.
Company
Vertex is a global biotechnology company focused on scientific innovation and developing better outcomes for patients.
What you will do
- Lead scientific and operational statistical work across multiple clinical trials, observational studies, and real-world data investigations.
- Lead biostatistics projects or major project components, including work allocation, review, and strategic technical contributions.
- Design and implement statistical methods at study and project level, and author Statistical Analysis Plans, TFL shells, xFDR plans, KRMs, and Data Dissemination Plans.
- Collaborate with statistical programming and cross-functional teams to deliver high-quality TFLs and contribute to clinical study reports.
- Provide statistical guidance to internal review boards, regulators, payers, and other external stakeholders.
- Author or co-author methodological publications, study publications, and posters while contributing to advanced departmental initiatives.
Requirements
- Ph.D. in Statistics or Biostatistics, or an equivalent combination of education and experience.
- Typically seven years of experience with a Ph.D. or equivalent experience.
- In-depth competence with SAS and R statistical software.
- In-depth understanding of advanced statistical methods used in drug development.
- Experience with NDA/MAA submissions and direct dealings with US and European regulators.
- Strong critical thinking, logical problem-solving, written communication, verbal communication, and cross-functional collaboration skills.
Nice to have
- Prior staff management experience.
- Experience presenting to peer protocol review committees, statistical review forums, or other senior review boards.
Culture & Benefits
- Continuous learning focused on advances in AI, technology, automation, and industry trends.
- Medical, dental, and vision benefits.
- Generous paid time off, including summer and winter company shutdowns.
- Educational assistance, including student loan repayment programs.
- Commuting subsidy, matching charitable donations, and 401(k).
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