Principal Biostatistician (FSP -Permanent Homebased)

IQVIA; England; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global provider of clinical research services is seeking a Principal Biostatistician to drive quality statistical planning and analysis in support of pharmaceutical development. The role involves serving as a biostatistical consultant, leading studies, and ensuring compliance with regulatory standards. Ideal candidates should possess a Master’s or PhD in Biostatistics, expertise in statistical methods for clinical trials, and strong collaboration skills.

Qualifications

• Experience in serving as statistical lead for regulatory submissions.
• In-depth knowledge of clinical research regulatory requirements and GCP.
• Expert in strategically collaborating with clinical and drug development experts.

Responsibilities

• Serve as biostatistical consultant for other departments.
• Lead studies at an operational level.
• Produce or perform quality control review of sample size calculations.

Skills

Expert in a broad range of complex statistical methods

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

Education

Master’s or PhD degree in Biostatistics or related field

Job description

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.

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.
• Lead 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.
• Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses.
• Perform as subject matter expert (SME).
• Identify risks to project delivery and/or quality, lead in a way to minimize risks.
• Anticipate risks to avert need for study‑level escalations, support lead in implementing risk mitigation actions.
• Lead the database lock and unblinding process for the statistical team.
• Participate on the biostatistics randomization team (draft randomization specifications and/or perform quality control (QC) review of randomization schedules).
• 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

• Master’s 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.