Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
The company offers a flexible environment and interesting earning opportunities, including an equity-based incentive plan. CONTACT US Our consultant Matthias Hennig will be happy to answer any questions you may have on +49 891895520-19. The Rau Consultants guarantee objective information and will only pass on your data after explicit approval.
Nexira offers not only an appropriate salary but also a caring environment of mutual respect in which every employee can develop further. CONTACT Our consultant Matthias Hennig will be happy to answer any further questions you may have at +49891895520-19. Rau Consultants vouch for objective information and will only pass on your data after explicit authorisation.
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 expertsExperience 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 RExcellent 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.