обновлено 4 дня назад
Biostatistics Associate Director (Biotechnology)
174 800 - 262 200$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Biostatistics Associate Director (Biotechnology) (clinical trials/RWD): Leading sophisticated statistical analyses and biostatistics projects for drug development with an accent on advanced methodology, Statistical Analysis Plans, and cross-functional clinical study delivery. Focus on designing study-level analyses, reviewing TFLs and programming specifications, supporting regulatory interactions, and solving complex statistical issues independently.
Location: Boston, Massachusetts, 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 the development of medicines.
What you will do
- Lead statistical work for multiple clinical trials, observational studies, and real-world data investigations.
- Lead biostatistics projects or major project components, including work allocation and review.
- Design and implement study- and project-level statistical methods using advanced drug-development approaches.
- Author Statistical Analysis Plans, TFL shells, Cross-functional Data Review plans, Key Reports Memos, and Data Dissemination Plans.
- Collaborate with statistical programming and cross-functional teams to deliver high-quality analyses, clinical study reports, publications, and posters.
- Support interactions with regulators, payers, review boards, and internal senior review committees.
Requirements
- Ph.D. in Statistics or Biostatistics, or an equivalent combination of education and experience.
- Typically seven years of experience with a Ph.D.
- 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 U.S. or European regulators.
- Strong critical thinking, problem-solving, written communication, verbal communication, and collaboration skills; prior staff management experience is typical.
Culture & Benefits
- Hybrid or on-site work through the Flex @ Vertex program.
- Medical, dental, and vision benefits.
- Generous paid time off, including week-long summer and winter company shutdowns.
- Educational assistance, student loan repayment, commuting subsidy, matching charitable donations, and 401(k).
- Support for continuous learning in AI, technology, automation, and industry trends.
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