2 месяца назад
Statistical Scientist Director (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Statistical Scientist Director (Biostatistics): Leading statistical strategy and design for complex clinical trials in biotech and pharma with an accent on regulatory alignment, innovative trial frameworks, and sponsor communication. Focus on developing adaptive or Bayesian designs, ensuring high-quality statistical deliverables, and managing regulatory submissions for FDA and EMA.
Location: United Kingdom
Company
is a CRO helping biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines and diagnostics.
What you will do
- Lead statistical strategy for complex client studies, serving as the primary point of contact for sponsors and internal teams.
- Design innovative trial frameworks, including sample size estimation, adaptive, and Bayesian models.
- Oversee and develop key statistical deliverables, such as Statistical Analysis Plans (SAPs), randomization specifications, and CSR contributions.
- Provide expert guidance on regulatory guidelines from agencies including FDA, EMA, and PMDA.
- Manage biostatistics projects, overseeing budgets, scope, and timelines for stand-alone work.
- Support business development through bid defenses, RFP strategy, and scientific relationship building.
Requirements
- Advanced degree (MS or PhD) in Statistics or a closely related field.
- 15+ years of experience in clinical trials design and analysis, preferably within a CRO environment.
- Proven track record of implementing innovative statistical designs and analysis.
- Strong proficiency in SAS and R programming.
- Deep knowledge of CDISC standards and experience interacting with regulatory agencies (FDA, EMA).
- Willingness to travel approximately 20%.
Culture & Benefits
- Commitment to professional growth and providing opportunities to excel.
- Environment that emphasizes flexibility and work-life balance.
- Culture where individual ideas influence workflows and voices are valued.
- Opportunity to contribute to life-saving medical innovations.
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