Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position?
À±½·ÊÓƵ is seeking a Lead/Principal Statistician to provide strategic support and leadership within a cross-functional team focused on oncology studies. This role involves contributing to study design, protocol development, and statistical analysis plans, ensuring high-quality data management and regulatory compliance. You will act as the statistical expert for clinical development programs, employing advanced methodologies and innovative trial designs. This permanent position is fully remote based within United Kingdom or France.
Responsibilities:
- Provide statistical expertise in study design and protocol development.
- Conduct sample size and power calculations, and simulations.
- Develop statistical analysis methodologies and plans.
- Oversee blinded in-trial data quality review and pre-database lock data control.
- Support the development of table, listing, and figure templates.
- Manage programming and production tasks.
- Oversee contract or CRO resources.
- Prepare and document clinical regulatory submission packages.
- Ensure adherence to CDISC standards and regulatory requirements.
- Collaborate effectively with multidisciplinary teams and external agencies.
Key Skills and Requirements:
- Expertise in oncology clinical development and regulatory submissions.
- Strong knowledge of statistical theory and methods.
- Proficiency in SAS and R programming for data management and analysis.
- Excellent communication, leadership, and intercultural skills.
- Ability to make informed decisions in ambiguous situations.
- Proficiency in MS Word, Excel, and PowerPoint.
- Sound understanding of clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC).
- Master's degree in Biostatistics or Statistics; Ph.D. preferred.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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