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

IQVIA LLC; Frankfurt; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A global clinical research services provider is looking for a Principal Biostatistician to lead statistical analysis in pharmaceutical development. The role requires a Master's or PhD in Biostatistics and expertise in complex statistical methods. Key responsibilities include liaising with cross-functional teams, serving as statistical lead on projects, and ensuring compliance with regulatory standards. This position offers an opportunity for significant impact in advancing medical treatments in a home-based work environment.

Qualifikationen

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

Aufgaben

• Liaise with cross-functional teams for statistical planning and analysis.
• Lead biostatistician on major projects and contribute to clinical development plans.
• Review statistical deliverables and provide expert input.

Kenntnisse

Expertise in complex statistical methods

Strong working knowledge of SAS or R

Excellent communication skills

Proactive problem solving

Ausbildung

Masters or PhD in Biostatistics

Tools

SAS

R

Jobbeschreibung

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

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

Apply locations Frankfurt, Hesse, Germany Solna, Sweden Turku, Finland Madrid, Spain Brussels, Brussels-Capital Region, Belgium time type Full time posted on Posted Yesterday job requisition id R1465597

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.

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
• 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

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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.