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.
Sie arbeiten mit Partner:innen bei länderspezifischen Zulassungen in Abstimmung mit Regulatory Affairs zusammen und erstellen monatliche und quartalsweise Umsatz- und Pipeline-Reports. Was bieten wir Ihnen? Ein wertorientiertes Unternehmen mit Herz und Vision. Ein zukunftsorientierter und sicherer Arbeitsplatz bei einem der führenden mittelständischen Medizintechnikunternehmen.
Sie arbeiten mit Partner:innen bei länderspezifischen Zulassungen in Abstimmung mit Regulatory Affairs zusammen und erstellen monatliche und quartalsweise Umsatz- und Pipeline-Reports. Was bieten wir Ihnen? Ein wertorientiertes Unternehmen mit Herz und Vision. Ein zukunftsorientierter und sicherer Arbeitsplatz bei einem der führenden mittelständischen Medizintechnikunternehmen.
Your Responsibilities: Supporting supply chain processes in the context of M&A integrations and tech transfers, including further development of processes Guiding and training junior specialists and coordinating cross-functional project teams Coordinating with internal and external partners and contract manufacturers to ensure smooth integration and efficient operations (e.g., in conference calls and on-site meetings) Ensuring product availability in key markets: Overall overview and monitoring of production, transport, or release status down to the warehouse Preparing and presenting decision-relevant analyses, reports, and recommendations for action to senior management. Presenting project progress and critical issues to steering committees Your Profile: Completed degree in business administration, engineering, or a comparable field Required professional experience: 5 years, ideally in the area of supply chain or project management Alternatively, you have experience in regulatory affairs, quality assurance, or pharmacovigilance You already have some experience in coordinating cross functional teams and complex projects You are characterized by analytical thinking and a structured and results-oriented approach to work You communicate and negotiate confidently in German and English and have a good working knowledge of MS Office; knowledge of SAP is an advantage Your way of working is proactive, solution-oriented and communicative Unser Angebot: A growing company with a diverse and open-minded working environment with employees from around 40 different countries Flexible working models adapted to your needs (e.g. up to 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or meal costs.
POSITION Responsible for leading and driving Food Safety, Quality and Regulatory strategic focusses and culture to ensure success of Fonterra’s strategic objectives Managing a team of professionals, 3 direct and 4 indirect reports, and supporting and further developing an inclusive and high performance culture Ensuring the Food Safety & Quality priorities and resources are aligned with business needs, working closely together with a.o.
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.