Principal biostatistician

neues Angebot (08/03/2020)

stellenbeschreibung

Job Description MorphoSys' mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich! We would like to fill the following vacancy as soon as possible:

Principal Biostatistician (gn) Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with leading edge knowledge and the overall product strategy Lead the development of the statistical analysis plan for clinical trials and historical control comparisons Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results for CSRs / ISE / ISS Provide guidelines and standards to CROs to ensure quality of deliverables Represent Biostatistics in meetings with cross-functional project teams ensuring adherence to FDA / ICH guidelines, Good Clinical Practices, and regulatory requirements Contribute to interactions with external review boards / ethics committees, external consultants and key opinion leaders Contribute in process development including writing SOPs and mentor junior members of the team Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings Masters or PhD in the field of Medical Biometry with ideally five or more years industry experience Comprehensive knowledge and prior experience of advanced statistical methodology in clinical trials that apply to Phase I-IV clinical trials, adaptive study design, Bayesian analysis and regulatory requirements relating to clinical development of drugs Ability to initiate, drive and implement novel methods and innovative trial designs, including the development and review of study related documents (e. g. Statistical Analysis Plan, Statistical part of Study Protocols, Case Report Form, Data Management Plan, IDMC Charter) Profound knowledge of statistical software

"Base SAS", "SAS Macros", "
Addplan
" and "R"
Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards / imple-men-tation guides, 21 CFR Part 11, and FDA guidelines Expertise in medical research, especially oncology and inflammatory diseases Experience in calculating probability of study success, modelling and simulation Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure and in a team environment to meet established deadlines Experience in working in matrix organizations Team player with well-developed interpersonal abilities Excellent written and oral communication skills in English, including grammatical / technical writing skills Creative working in X-functional teams Young and dynamic Biostatistics team Opportunities to work in Phase 3 studies and potential submissions Open and appreciative corporate culture Multicultural environment Working in an attractive, high-quality equipped building with restaurant Free sports and language courses>

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