d) at IQVIA

Frankfurt, Hessen, Germany

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

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

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 (drafts 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

Skills

Biostatistics

Statistical Planning

Statistical Analysis

Statistical Reporting

Clinical Trials

Protocol Development

Analysis Plans

Regulatory Compliance

Risk Management

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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