Zürich Metropolitan Area
• Independently designing, analyzing and interpreting clinical studies at a compound level for early phase or less complex programs. • Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions. • Improving and using standards to maximize global data integratability, interpretability and compound level efficiency • Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables. • Independently representing Statistics function in interactions with regulatory authorities.
Responsibilities: - Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis. - Perform protocol development, sample size calculation, protocol and CRF review. - Advise data management staff on database design, and critical data. May advise on validation checks. - Write statistical sections of integrated reports. - Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data). - Act as statistical team lead for single complex studies or groups of studies. - Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements. - Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings. - Manage customer relationships. - Provide training and guidance to lower level and new staff.
Main activities: • Focus on supporting Pharmacovigilance and Epidemiology departments Particular attention to signal detection • Provides expert consultation and advice in quantitative/statistical, experimental de-sign, and data management issues. Works with team to develop clinical protocols, analysis plans and final study reports for clinical development projects. Plans, coordinates, and produces statistical analyses and summaries in support of product development. • Member of core clinical cluster team, attend meetings as and coordinates activities for assigned clinical trials with internal data management and programming staff, medical writing and regulatory affairs. • Ensure that clinical development projects meets scientific, regulatory, quality, and commercialization requirements • Plan and track project level activities for B&SR. • Support submission activities, like ISS, ISE, briefing books. • Interact with Clinical Data Management as appropriate. • Interact with Health Authorities and external consultants as appropriate. • Coach and mentor cluster Statistician(s)
Main activities: • Focus on supporting Pharmacovigilance and Epidemiology departments Particular attention to signal detection • Provides expert consultation and advice in quantitative/statistical, experimental de-sign, and data management issues. Works with team to develop clinical protocols, analysis plans and final study reports for clinical development projects. Plans, coordinates, and produces statistical analyses and summaries in support of product development. • Member of core clinical cluster team, attend meetings as and coordinates activities for assigned clinical trials with internal data management and programming staff, medical writing and regulatory affairs. • Ensure that clinical development projects meets scientific, regulatory, quality, and commercialization requirements • Plan and track project level activities for B&SR. • Support submission activities, like ISS, ISE, briefing books. • Interact with Clinical Data Management as appropriate. • Interact with Health Authorities and external consultants as appropriate. • Coach and mentor cluster Statistician(s)
Main activities: • Providing high quality statistical support/consultancy to clients and managing projects on a variety of therapeutic areas (Pulmonary Arterial Hypertension/Pulmonary Vascular Disease, Diabetes, Parkinson’s Disease, Genitourinary/Sexual Health, Cardiovascular & Metabolic Diseases [Growth Retardation], Methodology Studies [Pain, Allergy & Respiratory], Non-Clinical Studies) • Advising clients on the design and analysis of clinical trials • Producing and QC of sample-size estimates, randomization schedules and statistical sections from protocols • Production of Reporting and Analysis Plans (including table mock-ups) for phase II, III and IV studies • Production and QC of Tables, Figures and Listings and statistical reports • Reviewing of clinical study reports for phase III studies • Providing ad-hoc analyses and production of exploratory reports