Associate Director/Senior Manager Biostatistics - Rare Disease

Proclinical Staffing; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is looking for an Associate Director/Senior Manager in Biostatistics to lead innovative clinical trials focusing on rare diseases. This role involves driving strategic input into study design, ensuring data management excellence, and overseeing regulatory submissions. The ideal candidate will possess a strong understanding of advanced statistical methods, SAS and R programming skills, and proven leadership abilities. Join a forward-thinking company dedicated to making a tangible difference in the world of life sciences, where your expertise will play a crucial role in advancing clinical research and improving patient outcomes.

Qualifications

• Proven experience in clinical biostatistics with a focus on rare diseases.
• Strong ability to manage multiple clinical trials and ensure quality control.

Responsibilities

• Provide statistical expertise in clinical planning and study design.
• Oversee preparation of clinical regulatory submission packages.
• Conduct sample size calculations and develop statistical analysis plans.

Skills

Advanced Statistical Methods

SAS Programming

R Programming

Communication Skills

Leadership Abilities

Clinical Regulatory Requirements

Quality Control Processes

Education

Ph.D. in Biostatistics or Statistics

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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.

Proclinical 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 [e-mail].

Apply Now:

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