Idorsia Pharmaceuticals Ltd I

Senior Expert Statistician (BB-205ED)

Gefunden in: Xpatjobs CH

About Idorsia Pharmaceuticals Ltd Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into one of Europes leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet the ideal constellation to bringing R&D efforts to business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets. The Idorsia Biometry department is looking for a highly experienced Statistician, supporting one or more Therapeutic Areas as statistical leader. Job Requirements: Function as a Project Statistician coordinating all statistical aspects across clinical studies within a specific project in one or several Therapeutic Area(s) Function as reviewer, consultant, and technical expert to the Therapeutic Area colleagues in discussions on scientific/regulatory/drug development issues associated with proposals and strategies to demonstrate either the efficacy, safety, or both of a compound in a defined indication Provide proposals and advices on successful approaches that can be useful in constructive critiques of study protocols, address the role the study will play in the overall drug development plan and other drug development strategies that rely on sound study designs, and prospective Statistical Analysis Plans Assess appropriateness of the study design in relation to study objectives, relevancy of endpoints (primary, secondary, etc.), clarity of the decision rule for efficacy assessment, multiplicity and maintenance of type I error rate, sample size consideration and power, randomization plan, interim looks, rationale for and plan for interim analysis & related infrastructure, plan for design modifications (such as sample size re-estimation), treatment of missing data and dropouts, alpha spending functions, and planned methods of analysis including meta-analysis combining two or more studies Manage administratively and functionally statisticians at various levels with respect to deliverables, processes, and professional development Statistical expert consultant across TAs in modeling, simulation, and endpoints research Expert in statistical methodology; ensure effective state-of-the-art methods are used in support to clinical projects Identify and evaluate opportunities to improve and harmonize methodological procedures and technology within Biostatistics; conducting research in applied statistical methods as appropriate; and introduce innovative trial designs and analyses Be accountable for all aspects of project management (quality, timelines, resource planning etc.) Take ownership of statistical and scientific robustness either directly as a trial statistician, project statistician, or in a supervisory role Supervise the writing of the statistical section of the protocol, SAP, and CSRs Oversee statistical tasks outsourced to external service providers Direct involvement or supervision of the development of CDPs and/or drug submission dossiers Interact with regulatory authorities on statistical issues on assigned projects/TA Defend statistical positions in internal and external meetings, including regulatory interactions Participate in Clinical Developments / Biometry''s Departments standardization efforts Review and anticipate resource requirements for existing projects Support continuous improvement, acceleration and quality of working procedures and outputs in the area of statistics as well as the enhancement of best statistical practices Candidates Requirements PhD or MSc in Statistics or related disciplines. Minimum of 15 years overall experience in Statistics of which at least five years within a similar position in Clinical Development in the Pharmaceutical Industry, or Clinical Research Organizations In-depth knowledge and expertise in Statistics, and its applications to clinical studies as reflected through the persons track record. Excellent project management skills (technical and people related) Excellent working knowledge of SAS and software for sample size estimations. Excellent knowledge of international clinical research regulations and requirements Proven track record of acting as subject matter expert supporting diverse teams within a broad set of therapeutic areas and all phases of clinical drug development Proven record of successfully interacting within a complex and challenging matrix environment Solution oriented with a sense of urgency and high customer orientation Proactive, pragmatic, with a proven track record of driving things t

calendar_todayvor 5 Tagen


location_on Allschwil , Basel-Landschaft, Schweiz

work Idorsia Pharmaceuticals Ltd

Ich ermächtige ausdrücklich die Bedingungen und Konditionen

Ähnliche Jobs