Principal Biostatistician (FSP -Permanent Homebased)

IQVIA; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading clinical research organization in France seeks a Principal Biostatistician to drive quality statistical analysis for pharmaceutical development. Responsibilities include serving as a consultant, leading major projects, and ensuring regulatory compliance. Candidates should have a Master's or PhD in Biostatistics, expertise in statistical methods, and strong knowledge of SAS or R. This role supports the development of innovative medical treatments.

Qualifications

• Expert knowledge applies to Phase 2-3 clinical trials.
• Experience as statistical lead for regulatory submissions.
• Knowledge of GCP and ICH guidelines.

Responsabilités

• Drive statistical planning and reporting in clinical trials.
• Serve as a biostatistical consultant for the department.
• Lead the database lock and unblinding process.

Connaissances

Expert in complex statistical methods

Strong working knowledge of SAS or R

Excellent communication skills

Collaboration skills

Independent problem solving skills

Formation

Masters or PhD in Biostatistics or related field

Outils

SAS

R

CDISC Data Standards

Description du poste

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.

Key Responsibilities

Leadership

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

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.