2 часа назад
Statistical Project Leader (Rare Disease)
148 500 - 214 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Statistical Project Leader (Rare Disease): Leading statistical strategy and execution for clinical development projects and complex late-phase studies with an accent on statistical validity, regulatory submissions, and cross-functional scientific leadership. Focus on planning study activities and resources, representing statistics in regulatory meetings, mentoring statisticians, and developing innovative solutions for clinical trial decision-making.
Location: Cambridge, MA; US and Puerto Rico residents only
Salary: $148,500–$214,500 per year
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience, data, and digital platforms.
What you will do
- Lead statistical strategy and execution for moderate, complex, and late-phase rare disease clinical development projects.
- Direct statistical support for clinical development, medical affairs plans, studies, and submissions.
- Ensure the quality, relevance, and scientific validity of statistical work for regulatory authorities, medical journals, and other external stakeholders.
- Plan and track project timelines, activities, resource requirements, and allocation across projects.
- Collaborate with clinical and cross-functional teams, CROs, data monitoring committees, statistics leaders, and senior leadership.
- Represent statistics in regulatory meetings and scientific or technology working groups while mentoring junior staff.
Requirements
- PhD or master’s degree in statistics, biostatistics, applied mathematics, bioinformatics, computational biology, data science, or a related quantitative or scientific discipline.
- PhD holders: at least 5 years of experience; master’s degree holders: at least 7 years of experience in pharmaceutical, biotech, biologics, medical device, diagnostics, or related industries.
- Strong knowledge of advanced statistical concepts and techniques and pharmaceutical clinical development.
- Experience with clinical development or post-marketing activities, including submissions and interactions with regulatory agencies or other external stakeholders.
- Strong project and study management, interpersonal, communication, and mentoring skills.
- Must be a resident of the United States or Puerto Rico.
Nice to have
- Experience in the rare disease or rare blood disorders therapeutic area.
- Experience representing an organization in consortia or professional associations.
- Academic or research experience in a relevant quantitative or scientific discipline.
Culture & Benefits
- Supportive, future-focused R&D environment centered on scientific innovation.
- Career development opportunities through promotion or lateral moves, including international opportunities.
- Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Work on AI, data, and digital platforms supporting drug discovery and development.
- Focus on work-life balance and a culturally inclusive workplace.
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