60 минут назад
Principal Biostatistician (Oncology) - FSP
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Biostatistician (Oncology) - FSP (Clinical Trials/Hematological Malignancies): Providing strategic statistical leadership for oncology clinical trials, including studies in multiple myeloma, leukemia, and lymphoma, with an accent on CDISC-compliant SDTM quality control and clinical development methodology. Focus on leading statistical activities, interpreting study results, supporting regulatory deliverables, and collaborating with cross-functional clinical development teams.
Location: 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
- Provide principal-level statistical leadership for oncology clinical development programs and studies.
- Lead and contribute to statistical activities across clinical trials as the primary statistical representative on assigned studies.
- Review and oversee quality control of SDTM datasets and related deliverables for CDISC compliance.
- Collaborate with Statistical Programming, Data Management, Clinical Operations, and Regulatory teams to deliver accurate and timely statistical outputs.
- Support the interpretation and communication of study results to technical and non-technical stakeholders.
- Contribute to study design, protocol development, statistical methodology, and regulatory-quality deliverables.
Requirements
- Advanced experience as a Principal Biostatistician in a pharmaceutical, biotechnology, or CRO environment.
- Strong experience in oncology clinical development, particularly hematological malignancies such as multiple myeloma, leukemia, and/or lymphoma.
- Practical expertise in CDISC standards, including SDTM, and in quality control of SDTM datasets and related outputs.
- Strong understanding of statistical principles and clinical trial methodology.
- Ability to work effectively with cross-functional teams, influence stakeholders, and communicate statistical concepts clearly.
Nice to have
- Experience serving as Lead Study Statistician.
- Knowledge of clinical trial statistical design and study planning.
- Experience supporting regulatory submissions and interactions with health authorities.
- Familiarity with advanced statistical programming tools and industry-standard processes.
Culture & Benefits
- Full-time employment within a global clinical research and healthcare intelligence organization.
- Cross-functional collaboration across clinical development, data, programming, operations, and regulatory teams.
- Work focused on accelerating the development of innovative medical treatments and improving patient outcomes.
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