Principal Biostatistician , FSP - Permanent Homebased (m/w/d)

Nanosep AB; Reading; Remote; GBP 60,000 - 85,000; Full time

Job summary

A leading global provider in clinical research is looking for a Principal Biostatistician to lead statistical planning and support important pharmaceutical development activities. This role involves collaboration with cross-functional teams, ensuring compliance with regulations, and contributing to major clinical projects, offering significant professional growth within the life sciences industry.

Qualifications

• Expert in a broad range of complex statistical methods for Phase 2-3 clinical trials.
• In-depth knowledge of clinical research regulatory requirements.
• Experience in serving as lead statistician for regulatory submissions.

Responsibilities

• Drive quality statistical planning, analysis, and reporting for pharmaceutical development.
• Serve as biostatistical consultant and participate in regulatory meetings.
• Lead major projects and review protocols and analysis plans.

Skills

Statistical methods

Communication

Problem solving

Collaboration

Education

Masters or PhD degree in Biostatistics or related field

Tools

SAS

R

Job description

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Job Overview

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

Job Overview

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

Leadership

Key Responsibilities:

Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company

Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee

Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication

Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections

Leading studies at an operational level

Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures

Consult on operational/statistical/therapeutic area topics

Knowledge Sharing

Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses

Performs as subject matter expert (SME)

Risk Management

Identifies risks to project delivery and/or quality, leads in a way to minimize risks

Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions

Lock And Unblinding Process

Leads the database lock and unblinding process for the statistical team

Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules)

Statistical Expertise

Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports)

Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data)

Provide expert review of ADaM reviewers guide (ADRG) and metadata

Perform senior biostatistical review (SBR)

Produce or perform quality control review of sample size calculations for complex studies

Requirements

• Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry
• Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials
• Expert in strategically collaborating with clinical and drug development experts
• Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries
• In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong working knowledge of SAS or R
• Excellent knowledge of CDISC Data Standards
• Superb communication and collaboration skills
• Independent and pro-active problem solving skills
• Rare disease and immunology experience is greatly preferred.
  
  

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  IT System Data Services

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