Principal Biostatistician (FSP -Permanent Homebased)

IQVIA; Frankfurt; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading global provider of clinical research services is seeking a Principal Biostatistician in Frankfurt, Germany. The role involves leading statistical planning, analysis, and reporting for clinical trials, ensuring compliance with regulatory guidelines. Ideal candidates should possess a Masters or PhD in Biostatistics, strong skills in statistical methods, and experience in preparing submissions. This position offers the opportunity to contribute to impactful medical treatments.

Qualifikationen

• Experience in regulatory submissions and preparation of datasets.
• In-depth knowledge of clinical research regulatory requirements.
• Strong working knowledge of CDISC Data Standards.

Aufgaben

• Liaise with cross-functional teams for statistical planning and reporting.
• Serve as a resource for the department and ensure compliance.
• Lead major projects and contribute to clinical development plans.

Kenntnisse

Expert in statistical methods for Phase 2-3 clinical trials

Collaboration with clinical and drug development teams

Strong SAS or R knowledge

Excellent communication skills

Pro-active problem solving

Ausbildung

Masters or PhD in Biostatistics or related field

Tools

SAS

R

Jobbeschreibung

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.