1 час назад
Associate Biostatistics Director (Clinical Trials)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Biostatistics Director (Clinical Trials): Leading statistical strategy, study design, analysis, and regulatory submissions for clinical development programs with an accent on Bayesian methods, adaptive designs, predictive modeling, and simulation. Focus on defining statistical analysis plans, evaluating Go-No Go criteria and technical success probabilities, and representing Biostatistics in interactions with FDA, EMA, and PMDA.
Location: Permanent home-based role in Reading, Berkshire, United Kingdom
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead the full scope of Biostatistics activities for clinical development programs within a therapeutic area.
- Define statistical strategies for study design, execution, data analysis, and regulatory submissions.
- Contribute to clinical development plans, governance reviews, and cross-functional Study Executive and Clinical Development Teams.
- Plan interim, final, and integrated analyses and ensure accurate, timely reporting.
- Represent Biostatistics in interactions with regulatory authorities including FDA, EMA, and PMDA.
- Interpret results and prepare study reports, regulatory documents, abstracts, posters, and presentations.
Requirements
- PhD or MS in Biostatistics, Statistics, or a related field.
- At least 8 years of experience in clinical trial statistics, preferably in a pharmaceutical or CRO setting.
- Advanced proficiency in SAS and R for statistical programming and data analysis.
- Experience with Bayesian methods, predictive modeling, simulation techniques, adaptive designs, sample size calculations, and interim analyses.
- Experience defining statistical analysis plans, leading regulatory submissions, and applying regulatory statistical guidance.
- Strong communication and collaboration skills with clinical and regulatory teams.
Culture & Benefits
- Permanent home-based working arrangement.
- Work focused on clinical research, innovative medical treatments, and improved patient outcomes.
- Collaboration with cross-functional and international regulatory stakeholders.
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