Associate Director, Biostatistics (FSP - Permanent Homebased)

IQVIA, Inc.; Reading; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Associate Biostatistics Director to lead statistical planning and analysis for clinical trials. This role involves collaborating with cross-functional teams to ensure scientific integrity and regulatory compliance. You will oversee major projects, contribute to clinical development plans, and serve as a key resource for statistical methodology. Ideal candidates will have extensive experience in biostatistics, particularly in Phase 2-3 clinical trials, and possess strong expertise in SAS or R. Join a forward-thinking company dedicated to improving patient outcomes through innovative research.

Qualifications

• 10+ years of experience in the life sciences industry.
• Expertise in statistical methods for Phase 2-3 clinical trials.

Responsibilities

• Lead major projects, including protocol review and report writing.
• Serve as a biostatistical consultant and engage in independent research.

Skills

Statistical Methods

SAS

R

Communication Skills

Problem-Solving Skills

Collaboration Skills

Knowledge of GCP and ICH Guidelines

Clinical Research Regulatory Requirements

Education

Masters in Biostatistics

PhD in Biostatistics

Tools

SAS

R

Job description

Job Overview:

As an Associate Biostatistics Director, you will liaise with cross-functional teams to drive the quality of statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. You will serve as a resource for the department, ensuring scientific integrity and regulatory compliance in applying statistical methodology to clinical trials. You will participate as a lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.

Key Responsibilities:

1. Leadership:

• Serve as a biostatistical consultant for department members and staff from other Biostatistics departments.
• Represent sponsors in meetings with regulatory agencies; participate as a Data and Safety Monitoring Committee member.
• Engage in independent research, teaching, presentations, and manuscript preparation.
• Lead major projects, including protocol review, analysis plan development, and report writing.
• Lead operational studies and provide expert review on statistical standards and validation procedures.
• Consult on operational, statistical, and therapeutic topics.

Knowledge Sharing:

• Stay informed of developments in biostatistics, clinical trial methodology, and regulatory requirements.
• Act as a subject matter expert (SME).

Risk Management:

• Identify and lead efforts to mitigate risks to project delivery and quality.
• Support in implementing risk mitigation actions.

Lock and Unblinding Process:

• Lead the database lock and unblinding process for the statistical team.
• Participate in the biostatistics randomization team, including drafting specifications and QC review.

Statistical Expertise:

• Provide expert review of statistical deliverables, data management, and analysis plans.
• Review and produce quality control of sample size calculations for complex studies.

Requirements:

• Masters or PhD in Biostatistics or a related field with 10+ years of relevant experience in the life sciences industry.
• Expertise in complex statistical methods for Phase 2-3 clinical trials.
• Experience as a statistical lead for regulatory submissions, including dataset preparation and regulatory interactions.
• Deep knowledge of clinical research regulatory requirements, GCP, and ICH guidelines.
• Strong proficiency in SAS or R.
• Excellent knowledge of CDISC Data Standards.
• Strong communication, collaboration, and problem-solving skills.
• Experience in rare diseases and immunology is preferred.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We create connections to accelerate the development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.