Associate Director/Senior Manager Biostatistics - Rare Disease

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

Job summary

An established industry player is looking for a bold and innovative Associate Director/Senior Manager in Biostatistics. This role is pivotal in driving strategic input for clinical study design, ensuring excellence in data management, and supporting regulatory submissions. You will lead multiple trials in rare diseases, collaborating with cross-functional teams to adhere to regulatory requirements. If you possess a Ph.D. in Biostatistics or Statistics and have significant experience in clinical biostatistics, this is an exciting opportunity to make a tangible difference in the world of science.

Qualifications

• Strong understanding of advanced statistical methods and innovative trial designs.
• Expertise in SAS and R programming for data management and statistical analysis.
• Sound knowledge of clinical and statistical regulatory requirements.

Responsibilities

• Provide statistical expertise in clinical planning, study design, and protocol development.
• Conduct sample size/power calculations and simulations.
• Oversee the preparation and integration of clinical regulatory submission packages.

Skills

Statistical Methods

SAS Programming

R Programming

Communication Skills

Leadership

Data Management

Regulatory Knowledge

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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