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.
Du sorgst für nahtlose Datenflüsse via Anaplan Connect, CloudWorks API sowie automatisierte Import- und Exportstrecken. Du gestaltest Dashboards, Reports und Analysen, die komplexe Daten verständlich machen. Du übernimmst Projektverantwortung in FP&A, Corporate Planning, Budgeting, Forecasting.
Reviews production schedules, work orders, engineering specifications, and related information to estimate manufacturing costs, design cost saving methods, and determine the effects of process changes on costs and quality; provides reports for management review, action, and control. Creation and maintenance of work instructions Works to reduce working capital by implementing methods and systems to ensure a more effective and efficient level of inventory.
Reviews production schedules, work orders, engineering specifications, and related information to estimate manufacturing costs, design cost saving methods, and determine the effects of process changes on costs and quality; provides reports for management review, action, and control. Creation and maintenance of work instructions Works to reduce working capital by implementing methods and systems to ensure a more effective and efficient level of inventory.
Du sorgst für nahtlose Datenflüsse via Anaplan Connect, CloudWorks API sowie automatisierte Import- und Exportstrecken. Du gestaltest Dashboards, Reports und Analysen, die komplexe Daten verständlich machen. Du übernimmst Projektverantwortung in FP&A, Corporate Planning, Budgeting, Forecasting.
Proven success in global communications roles, ideally within pharma/biotech or regulated industries; Experience in applied science communications is highly desirable.Proven experience working in a global, highly matrixed environment, collaborating across regions and functions and influencing cross-functional stakeholders.Fluency in German and English, both written and spoken. Reporting Relationship: Role that this position reports to: Director, Communications Business Partner CSL International Roles that report to this position: none What we offer Our benefit plan offers our employees numerous choices including such options as life insurance and retirement plan Up to two additional leave days for your personal wellbeing.
Ensures that initiatives are aligned with the business objectives and strategic philosophy Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval Responsible for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for site Sr. Management and Global Steering Committees Project Teams are responsible for completion of project lifecycle activities through performance qualification Influences teams to work collaboratively, to be customer focused and to deliver superior performance through personal leadership abilities, mentoring and effective communication.
Ensures that initiatives are aligned with the business objectives and strategic philosophy Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval Responsible for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for site Sr. Management and Global Steering Committees Project Teams are responsible for completion of project lifecycle activities through performance qualification Influences teams to work collaboratively, to be customer focused and to deliver superior performance through personal leadership abilities, mentoring and effective communication.
MS project server)Delivery Heatwave dataset for procured components based on BoMProgram Data Management (incl. data configuration) Implementation of digital workflows and lean management practices to secure continuous PM business process improvements, therefore also initiating and organizing workshops with relevant internal/external stakeholder Requirements: Work in the multi-functional PM Office team of specialists for costs/budget, risks and planningShow initiative, resilience, and persuasiveness when implementing the budget planning process towards the (functional and cross-functional) stakeholders of the organisationAbility to analyse and report cost performanceProcess-driven but also out-of-the-box thinking to improve the existing processes, methods and toolsOpen-minded and resilient person with high analytical skillsConceptual thinking as well as planning, organization and communication skills will be key to succesfully fill out the position.
You’ve got to be sharp, and you must be on your game every day… because you will be an essential part of everyday life. In this role you report to our Nordic CEO and the position is located in Stockholm, Sweden. You are a part of the regional Marketing and Communication team and network with a region we call MLEMEA, Mainland Europe, Middle East and Africa.
Participates in planning and reviewing medical sections of Clinical Trial Reports. Qualifications Medical degree from an accredited and internationally recognized medical school. Typically requires a minimum of 5-7 years' experience in clinical medicine.
Key Responsibilities: • Perform, plan co-ordinate, and implement the following for complex studies: - The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing - The programming of analysis datasets (derived datasets) and transfer files for internal and external clients - The programming quality control checks for the source data and to report the data issues periodically • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams • Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables • Use and promote the use of established standards, SOP and best practices • Provide training and mentoring to SP team members Requirements: • Bachelor's Degree in Maths, Computer science, Statistics, or related field • 7+ years’ Statistical Programming experience within the Life Science Industry • Strong Efficacy experience • Advanced knowledge of statistics, programming and/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro • Language • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you • Global exposure • Variety of therapeutic areas • Collaborative and supportive team environment • Access to cutting-edge and innovative, in-house technology • Excellent career development and progression opportunities • Work-Life Balance, with a strong focus on a positive well-being Unleash your potential!
You will work closely with local management and collaborate with Group Compliance in Hannover, gaining both operational exposure and strategic insight. You will report to the Compliance Manager based in Copenhagen. The compliance scope is rooted in corporate insurance, where due diligence primarily relates to sanctions and integrity risk in connection with corporate clients, brokers/intermediaries, and relevant third parties.
You will work closely with local management and collaborate with Group Compliance in Hannover, gaining both operational exposure and strategic insight. You will report to the Compliance Manager based in Copenhagen. The compliance scope is rooted in corporate insurance, where due diligence primarily relates to sanctions and integrity risk in connection with corporate clients, brokers/intermediaries, and relevant third parties.
In addition, establishing the tone and expectation for the 3M partnership within SID across the markets of International will be first order priority. The role reports to the Executive Director, IG Portfolio Lead, Commercial Operations International. Leadership Provide strong strategic and operational marketing expertise and guidance for SID and market brand leads within International Region impacting directly the marketing functional results within the Region given the position holder directs the execution of the SID marketing strategyAbility to lead, manage, and motivate cross-functional matrix teams across international markets; fostering a culture of continuous development and improvement within the marketing communityProvide brand leadership for 3M partnership and embed integrative ways of working that enables the business to benefit from cross-functional thinking and alignment as a constantLeads the execution of the 3M operational brand plan across the international region, influencing business decisions of General Managers, which makes the position holder responsible for the SID budget & P&LOwns and drives the operational brand planning process for portfolioCo-responsible to build talent and succession pipeline for above-market Marketing positions Strategic thinking Ability to generate and leverage insights to solve complex problems and to translate into action that helps course correct portfolio/brand performance where neededAbility to launch and build new brands and adept in managing brands through their lifecycle at an above-market and in-market levelProvide strategic thought partnership to the ED IG Portfolio Lead and to the Head of International Marketing for SID growth potential realisation Execution Develop aligned customer focused brand plans and enable consistent and disciplined implementation across the international regionImplement performance tracking and management system for SID brandsProven experience in driving operational delivery within the context of marketing in an international operating environmentBuild region-wide confidence in portfolio/brand strategies and plans, and establish a culture of good practice sharingEstablish strong relationships with key external stakeholders (e.g., physicians, patient associations, and professional/medical associations and societies) Position Qualifications and Experience Requirements Education: Graduate degree or equivalent required.
Support the Patient Services Manager (PSM) with administration of the monthly cryo billing reports and review of the month-end deferred revenue/income list. Managing all ICB quality queries and reporting monthly, quarterly, 6 monthly and annually as per the schedules for each ICB.
Key responsibilities Deal Execution & Financial Analysis Lead the preparation and execution of hotel sale assignments, pitches, and client proposalsDevelop and apply advanced financial models to assess strategic alternatives and capital structuresManage virtual data rooms, investment memorandums, and marketing deliverablesAnalyse market data, monitor financial trends, and prepare high-quality client presentations Client Relationship Management Build and sustain strong relationships with investors, operators, and partnersRepresent JLL at major industry conferences, networking events, and client meetingsCollaborate across regional and global JLL teams to deliver seamless cross-border solutions Team Leadership & Collaboration Manage direct reports and mentor junior team members to support professional growth Contribute to a high-performance, collaborative culture within the DACH and wider EMEA teamsMaintain accurate records in JLL’s CRM and research databasesUndertake site visits and property inspections with clients and investors Qualifications required / Your profile University degree in Business Administration, Real Estate, Finance, Hotel Management or other related fieldsMinimum 5 years’ experience in hotel real estate, hospitality investment or a related capital markets fieldOutstanding academic and professional achievementExceptional financial modelling, analytical and market research skillsGreat attention to detailStrong team orientation and leadership skillsAbility to multi-task and thrive in a diverse and fast-paced environmentGreat interpersonal and communication skills to interact with external and internal stakeholders including senior managementAdvanced MS Office skills, especially in Excel, PowerPoint, Word and OutlookTrack record of initiative, analytical excellence, and delivering results in a fast-paced environmentFluent in German and English (both written and spoken) We offer Opportunity to work with the world’s leading hotel real estate advisory team, on some of the sector’s most significant transactionsDirect exposure to international capital marketsAccess to JLL’s global network and knowledge-sharing platformFlat hierarchy in a dynamic, collaborative, and supportive work environmentStrong recognition for high performance, with competitive rewards and career development opportunitiesParticipation in industry events to expand your professional network To apply Please submit your cover letter, CV and academic transcripts.
Proactive in achieving the highest standard of operation. Have good IT and report writing skills. Ability to work under pressure whilst remaining calm, clear thinking and able to deliver the required services to the client within given time constraints.