(Senior) Biostatstician (gn)

Einsatzort: Planegg

MorphoSys's 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:

(Senior) Biostatstician (gn)

Your Responsibilities:

  • 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

Your Requirements:

  • Masters or PhD in the field of Medical Biometry with ideally two to five years industry experience
  • Comprehensive knowledge of statistical methodology in design, analysis and regulatory requirements relating to clinical development of drugs
  • Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
  • Expertise in designing clinical trials, including the development 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 / implementation guides, 21 CFR Part 11, and FDA guidelines
  • Expertise in medical research, especially oncology and inflammatory diseases
  • Strong analytical and problem-solving capabilities
  • 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
  • Basic knowledge in German desirable

We offer:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Thank you for your in­ter­est! We are look­ing for­ward to re­ceiv­ing your perti­nent ap­pli­ca­tion doc­u­ments. For your ap­pli­ca­tion please use ex­clu­sive­ly our ca­reer por­tal www.morphosys.com/careers. We do not only of­fer ex­cel­lent ca­reer prospects, but sup­port you from the very start - al­so help­ing you move.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg