3 часа назад
Associate Director, Biostatistics (Oncology)
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 Director, Biostatistics (Oncology) (clinical trials and statistical methodologies): Leading statistical oversight across oncology clinical development programs, including protocols, SAPs, ADaM datasets, TLFs, and regulatory submissions with an accent on advanced methodology, scientific rigor, and quality. Focus on mentoring global biostatistics staff, advising emerging biopharma clients, supporting regulatory interactions, and leading bid defense activities.
Location: Frankfurt, Hesse, Germany; work from home with an international EU team
Company
is a global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead statistical consultation and analysis for Phase I–IV clinical programs, including protocol development, randomization, sample size assessment, efficacy evaluation, and data review.
- Review, approve, and develop Statistical Analysis Plans, analysis summaries, mock data displays, ADaM specifications, datasets, Tables, Listings, and Figures.
- Oversee statistical analyses, including hypothesis testing and modeling, while ensuring scientific rigor, quality, and consistency.
- Manage project timelines, tasks, resources, and delivery quality for internal and external clients.
- Serve as the project biostatistician for clients and regulatory agencies and support regulatory submissions.
- Mentor biostatistics staff across global regions, develop future Statistical Team Leads, and support training and departmental standards.
Requirements
- Master’s degree in Statistics, Biostatistics, or a related field with eight years of relevant CRO or biotech experience, or a doctorate with six years of relevant experience.
- Extensive oncology drug development experience across a broad range of indications.
- Advanced knowledge of statistical methods used in Phase I–IV clinical trials, with data handling and analysis experience.
- Experience with SAS Base and SAS Stat; familiarity with N-Query or S-Plus is also relevant.
- Knowledge of GCP, ICH, and FDA guidelines and regulations for clinical research.
- Strong communication, interpersonal, organizational, independent-working, and time-management skills.
Culture & Benefits
- Remote work with an international team.
- Fast-paced environment supporting smaller biotech and emerging biopharma clients.
- Exposure to innovative research groups across oncology, dermatology, medical devices, CNS, immunology, and cardiovascular studies.
- This role is not eligible for UK visa sponsorship.
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