Associate Director/Senior Manager Biostatistics - Rare Disease

TN United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a dynamic Associate Director/Senior Manager in Biostatistics focused on rare diseases. This pivotal role involves driving strategic input into clinical study design and ensuring excellence in data management. You will lead multiple clinical trials, oversee timelines, and maintain quality control while collaborating with cross-functional teams. Ideal candidates will possess a strong background in advanced statistical methods, SAS and R programming, and proven leadership abilities. Join a team dedicated to pushing the boundaries of science and making a tangible difference in the world.

Qualifications

• Ph.D. in Biostatistics preferred with significant experience in clinical biostatistics.
• Strong understanding of advanced statistical methods and innovative trial designs.

Responsibilities

• Provide statistical expertise in clinical planning, study design, and protocol development.
• Oversee the preparation and integration of clinical regulatory submission packages.
• Lead and drive submissions, ensuring adherence to regulatory requirements.

Skills

SAS Programming

R Programming

Statistical Analysis

Advanced Statistical Methods

Clinical Trial Management

Communication Skills

Leadership

Education

Ph.D. in Biostatistics or Statistics

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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Associate Director/Senior Manager Biostatistics - Rare Disease, London

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Client:

Proclinical

Location:

London, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

ae32df056250

Job Views:

3

Posted:

10.05.2025

Expiry Date:

24.06.2025

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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.