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 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.
Provide expert technical input to development projects by integrating real site-specific load insights. Prepare clear technical reports and documentation summarizing analyses and results. Support certification processes and claims investigations with deep technical understanding.
Provide expert technical input to development projects by integrating real site-specific load insights. Prepare clear technical reports and documentation summarizing analyses and results. Support certification processes and claims investigations with deep technical understanding.
To learn more please visit http://www.convatecgroup.com The Global Health Economics & Outcome Research Manager (HEOR) will be part of our Market Access and Reimbursement Centre of Excellence (COE) and report into the Director, Global Health Economics and Outcomes Research. This will be a pivotal role in supporting our Convatec Market Access capabilities our business strategy within the evolving global market access and reimbursement landscape.
As Chief Chemical Engineer / Manager, you will be the scientific authority for solid propellant production and a key leader in our production organization. You will have two direct reports (chemists/technologists) and report to the Chief Production Officer (CPO) based in Vojens, Denmark. Your main responsibilities will include: Own the chemistry of our solid propellants – develop, document, and validate all fuel formulations and recipe control standards Define and maintain critical process parameters (temperature, mixing time, vacuum, catalysts, etc.) and ensure robust process windows from lab scale to full-scale production Lead and manage the analytical laboratory: raw material testing, in-process testing, test methodologies, calibration, documentation, and data traceability Drive recipe change control – plan and execute pilot batches, validation, and transfer to production, including updates of SOPs and work instructions Conduct root-cause analysis in collaboration with Process Engineering and Maintenance to address recurring defects, quality deviations and process instability Ensure full batch traceability and strong HSE practices for hazardous materials (classification, storage, transport, and safe handling) Collaborate closely with Quality Control to define sampling plans, acceptance criteria and CAPA activities (Corrective and Preventive Actions) Contribute to supplier qualification and material approval, including definition and verification of technical specifications Continuously improve yield, scrap rate and recipe cost through optimization of formulations and process parameters Maintain and prepare documentation for ISO, AQAP and defense-quality audits related to chemical operations Lead, coach, and develop your team of chemists and technologists and help build a strong safety- and quality-driven culture on site We are looking for an experienced and hands-on chemical leader who thrives in a high-tech, safety-critical production environment and enjoys building something new.
As Chief Chemical Engineer / Manager, you will be the scientific authority for solid propellant production and a key leader in our production organization. You will have two direct reports (chemists/technologists) and report to the Chief Production Officer (CPO) based in Vojens, Denmark. Your main responsibilities will include: Own the chemistry of our solid propellants – develop, document, and validate all fuel formulations and recipe control standardsDefine and maintain critical process parameters (temperature, mixing time, vacuum, catalysts, etc.) and ensure robust process windows from lab scale to full-scale productionLead and manage the analytical laboratory: raw material testing, in-process testing, test methodologies, calibration, documentation, and data traceabilityDrive recipe change control – plan and execute pilot batches, validation, and transfer to production, including updates of SOPs and work instructionsConduct root-cause analysis in collaboration with Process Engineering and Maintenance to address recurring defects, quality deviations and process instabilityEnsure full batch traceability and strong HSE practices for hazardous materials (classification, storage, transport, and safe handling)Collaborate closely with Quality Control to define sampling plans, acceptance criteria and CAPA activities (Corrective and Preventive Actions)Contribute to supplier qualification and material approval, including definition and verification of technical specificationsContinuously improve yield, scrap rate and recipe cost through optimization of formulations and process parametersMaintain and prepare documentation for ISO, AQAP and defense-quality audits related to chemical operationsLead, coach, and develop your team of chemists and technologists and help build a strong safety- and quality-driven culture on site We are looking for an experienced and hands-on chemical leader who thrives in a high-tech, safety-critical production environment and enjoys building something new.