Director Biostatistician

JR United Kingdom; Chelmsford; On-site; GBP 40,000 - 70,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a statistician to coordinate and deliver methodological and statistical expertise. The role involves managing internal and external collaboration on multiple projects across various therapeutic areas. You will be pivotal in developing strategic plans for integrated analyses and ensuring compliance with international guidelines and standards. Attending meetings and providing statistical support will be key parts of your responsibilities.

Qualifications

• Experience in providing statistical and methodological support.
• Familiar with writing and reviewing statistical components of protocols.
• Proficient in selecting statistical methodologies for clinical studies.

Responsibilities

• Coordinates and delivers statistical expertise for clinical development projects.
• Manages operational aspects of statistical work outsourced to CROs.
• Collaborates with clinicians to interpret and communicate results.

Skills

Statistical expertise

Data analysis

Project management

Methodological support

Job description

Job Responsibilities (not limited to):

Coordinates, provides, and delivers methodological and statistical expertise and analyses. Supports both the Clinical Development portfolio and Strategic Medical Affairs in their support to Affiliates, ensuring compliance with international, regulatory guidelines, policies, and standards. Manages the operational aspects of statistical work outsourced to CROs.

Manages multiple projects across various therapeutic areas.

Participates in and presents at external meetings related to Statistics, such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.

Provides qualified statistical and methodological support to the EPD team, including input into Clinical Development Plans and study protocols. Responsible for selecting appropriate statistical methodologies and endpoint definitions during the design of clinical studies and for sample size determination. Writes or reviews the statistical components of protocols.

Briefs CROs on conducting statistical analyses of EPD Clinical Development studies. Reviews statistical analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures. Approves database lock and requests unblinding for analysis. Collaborates with clinicians to interpret and communicate results clearly to ensure correct understanding by all users.

Supports dossier submissions and responds to statistical queries related to filings.

Develops strategic and detailed plans for integrated analyses of internal compound databases, collaborating with Clinical teams to ensure proper execution.

Maximizes data potential through integration and utilization activities such as meta-analyses and data explorations.

Manages external statisticians working on clinical trial analyses, providing guidance on methodological and statistical deliverables.

Keeps abreast of statistical literature, attends conferences, and participates in courses to maintain high expertise and proficiency. Collaborates with other statisticians to learn new or improved methodologies.

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Created on 26/06/2025 by JR United Kingdom