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

Social network you want to login/join with:

Associate Director/Senior Manager Biostatistics - Rare Disease, London

Client:

Proclinical

Location:

London, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

ae32df056250

Job Views:

3

Posted:

10.05.2025

Expiry Date:

24.06.2025

Job Description:

We are seeking innovative thinkers to advance science and make a difference. Proclinical seeks an Associate Director/Senior Manager in Biostatistics focusing on rare diseases. This role involves strategic input into clinical study design, data management excellence, and supporting regulatory submissions. You will independently lead multiple projects, oversee trials in rare diseases, and manage 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 analysis.
• Excellent communication skills for effective cross-department interaction.
• Proven leadership and team collaboration abilities.
• Proficiency in MS Word, Excel, and PowerPoint.
• 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 clinical biostatistics experience.