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.
Refine and execute our go-to-market strategy and pipeline generation initiatives, supported by strong cross-functional collaboration and execution.Lead the Team: Inspire and support a regional sales team, fostering a performance-driven, customer-focused culture. Mentor direct reports by participating in client and prospect meetings and engaging other BW Papersystems resources as needed. Attract, develop, and retain top talent.Build External Relationships: Maintain and grow relationships with existing customers, key accounts, and channel partners.
Lead the Team : Inspire and support a regional sales team, fostering a performance-driven, customer-focused culture. Mentor direct reports by participating in client and prospect meetings and engaging other BW Papersystems resources as needed. Attract, develop, and retain top talent.
Key Responsibilities: ·Provides specialized administrative support in the development, implementation, and marketing of our two HR development programs ·Serves as a central point of contact between prospective employees, vendors, staff, other departments, and/or external constituencies on day-to-day operational, and administrative matters; assists with meetings, special projects, and/or general problem resolution ·Coordinates activities and administration of program objectives; this requires engaging internal and external stakeholders ·Monitors and administers program/project expenses; may develop or participate in the development of funding proposals for the program ·Writes, edits, and coordinates development of course catalogs, promotional materials, educational materials, training manuals, newsletters, and/or brochures, as appropriate to the program ·Maintains program/project records, researches information and gathers and computes various data; prepares special and/or one-time reports, summaries, or replies to inquiries, selecting relevant data from a variety of sources. ·Performs miscellaneous job-related duties as assigned Skills / Requirements: ·Sophomore, Junior, or Senior level college student seeking an HR degree ·Advanced knowledge of Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint) ·Very strong presentation and communication skills ·A very motivated individual who takes initiative and can work independently with minimal supervision ·Strong multi-tasker with ability to take direction from multiple sources WHY JOIN our DHL team?
Drive improvement to eliminate unacceptable risk and to achieve the required safety standards cost effectively. Report back to senior management on the findings and corrective action taken. To action/follow up all near miss/accident reports and liaise directly with the HSE for all reportable incidents.
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.
You regularly monitor the market and competition and derive concrete measures. You report regularly to the Fleet DACH Sales Management. What makes you stand out You have several years of experience in B2B field sales, ideally in fleet, mobility, or travel management.
Maintain detailed notes and summary information within the Service Request Module and provide a regular summary. Reporting Track and report actual seat demand versus projected seat demand at the building level.Reports the current supply and capacity, and forecasts inventory changes, site metrics, activity and opportunities.