职位描述

职位描述： Job facts - Purpose - The Statistical Scientist is responsible for providing high-quality statistical expertise to assigned Clinical Development studies or nonclinical projects. He/she looks beyond the purely statistical aspects, collaborating actively to promote rigor in the planning, conduct, and analysisof experiments, and in the interpretation of results. He/she operates with minimal supervision at the study level, receiving guidance from the project level statistician to ensure alignment. - In the clinical study setting the Statistical Scientist works closely with study team partners from biometrics, clinical science, safety science, operations, pharmacology, and regulatory. They collaborate to create of strategies to address drug development needs and design and execute appropriate studies. This includes input to protocols, review of case report forms, developing data analysis plans, and supporting the execution and interpretation of planned analyses. Effective collaboration with Operations, Data Management, and Statistical Programming personnel is essential. - Beyond study level contributions, the Statistical Scientist may also take ownership of early development projects or significant components of late-stage projects (e.g., serving as a submission team leader or setting up project level data monitoring committees)- These project level responsibilities will typically be accomplished with guidance from management and more senior statisticians. - Key Responsibilities & Accountabilities - Clinical Development: - l Member of clinical team, collaborating in preparation of Clinical Development Plans and target product profiles; typically lead statistician on cross-functional study management teams or sole statistician on early development project teams; - l Study Planning: Reviews study protocols, authors statistical sections of protocols, prepares the study randomization, develops the statistical and data analysis plans, develops independent data monitoring and endpoint committee charters; - l Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, review and approve analyses produced by statistical programming; - l Analysis & Reporting: Authors the clinical study report, provides input into global health authority documents and regulatory response for health authority submissions. Contributes to study publications and presentations. - Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling; - l Oversees the deliverables from Statistical CROs; - l Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation; - l Participates in health authority meetings. - Nonclinical Statistics: - l Study Planning: Provides experimental design and analysis strategies to nonclinical projects; - l Analysis and Reporting: Performs statistical analyses for nonclinical studies, provides input to IND and BLA submissions and to regulatory response to global health authority investigations related to marketed products, andcontributes to publications and presentations; - l Statistical Consulting: Provides statistical advice to nonclinical investigators and contributes to the development of statistics courses. - Functional Area: - l Understand and apply business requirements and processes. Participates in functional training; - l Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc. - l Participates in Biostatistics and cross-functional initiatives. Participates in the development of functional processes; - l Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications. - People Development and Management: - l Mentor other statisticians on requestWho you are - You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies- Where a job title is not considered the final definition of who you are, but the starting point. - l MSc or PhD in statistics, biostatistics, mathematics or similar areas of academic discipline; - l Good knowledge of English in a business environment; - l Experience in using statistical software; - l Good knowledge of theoretical and applied statistics; - l Very good knowledge and experience applying statistical methods to drug development; - l Good understanding of regulatory guidelines in a pharmaceutical research setting; - l Understands and applies Business requirements and processes; - l Understands and respects cultural differences when interacting with colleagues in the global work place; - l Accomplishes responsibilities with little supervision; - l Effective Communication and Collaboration Skills (including statistical consulting skills, interpersonal skil- ls to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative re- lationships with scientific and non-scientific partners); - l Good Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors); - l Good Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects); - l Evident Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems); - l Effective mentoring other statisticians.Who we are - At Roche, 91,700 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. - Roche is an equal opportunity employer. More Information related to This Position Click Here 职能类别： 生物工程/生物制药

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