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Job type: Permanent

Discipline: Programming

Location: United Kingdom

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.

̽��ϼ� is seeking an Assoc. Dir./Sr. Mgr. in Biostatistics with a focus on rare diseases. The role drives strategic input into clinical study design, ensures excellence in data management, and supports successful regulatory submissions. You will work independently on multiple projects, leading trials in rare diseases and overseeing timelines and quality control.

Responsibilities:

Provide statistical expertise in clinical planning, study design, and protocol development.
Conduct sample size/power calculations and simulations.
Develop statistical analysis methodologies and plans
Perform blinded in-trial data quality reviews and pre-database lock data quality control.
Oversee the preparation and integration of clinical regulatory submission packages.
Collaborate with cross-functional teams including clinicians, clinical operations, and regulatory affairs. Manage and review work from contract or CRO resources.
Lead and drive submissions, ensuring adherence to regulatory requirements.

Key Skills and Requirements:

Strong understanding of advanced statistical methods and innovative trial designs.
Expertise in SAS and R programming for data management and statistical analysis
Excellent communication skills with the ability to interact effectively across departments.
Proven leadership and team collaboration abilities.
Proficiency in MS Word, Excel, and PowerPoint.
Sound knowledge of clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC).
Ability to manage multiple clinical trials and oversee quality control processes.
Ph.D. in Biostatistics or Statistics preferred, with significant experience in clinical biostatistics.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.

Apply Now:

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.

̽��ϼ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽��ϼ� is acting as an Employment Agency in relation to this vacancy.

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