Director (gn) Biostatistics

  • MorphoSys
  • 82152 Planegg, Germany
  • 30/08/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics

Job Description

Director (gn) Biostatistics

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!

Your Responsibilities:

  • Lead, mentor and provide line management function for the Trial Biostatisticians in MorphoSys’ headquarter, Planegg near Munich
  • Lead, mentor and evaluate performance of team to ensure career development and advancement of interpersonal skills. Develop team by assessing, coaching, providing appropriate training, setting goals, and reorganizing those who make significant contributions to business objectives
  • Ensure proper resource allocation for high quality deliverables for clinical trials as per company goals and agreed timelines
  • Plan, prioritize and track project level activities, including assessing and allocating resources
  • Create an integrated culture between Munich based colleagues and newly developed team in Boston, US, together with the US Team Lead Biostatistics & Data Management
  • Provide leadership and functional partnering with internal and external project teams
  • Clearly communicate basic statistical concepts to other scientists, non-scientists and senior management
  • Oversee the preparation and maintenance of all Biostatistics related SOPs and work instructions
  • Identify and implement solutions to issues and concerns related to Biostatistics tasks, including proactive prevention strategies based on metrics and forecasts
  • Review of clinical trial documents (e.g. protocols, statistical analysis plans, case report forms, data monitoring charters, clinical study reports)
  • Oversee the implementation of statistical methodology, statistical design and sample size estimation in the clinical protocol and statistical analysis plans
  • Support Trial Statisticians in CRO oversight for achieving study related goals in quality and in time: preparing statistical analysis plan, specifications for analysis files, consistency checks and tables, figures and listings
  • Contribute to data interpretation and writing statistical sections of clinical study reports
  • Preparation of statistical reports for regulatory submission and defending statistical conclusions with various regulatory agencies
  • Support and represent Biostatistics at Health Authority meetings, support and defend analyses and their interpretation
  • Strategic cross-functional collaboration in setting up and maintaining integrated drug development plans, contribute to development of study concepts, initial study designs as well as ‘Probability of Success’ calculations and defining success criteria
  • Support preparation of articles for publication or presentation at professional conferences
  • Participate in process development initiatives

Job Qualifications:

  • Master’s or doctoral degree in Biostatistics, Applied Mathematics or Statistics with 7 years industry experience
  • Ideally minimum of three to five years management experience, direct responsibility of team members
  • Experience in leading diverse team and worked in multi culture environment
  • Displayed examples of working cross-functionally and building intra- / inter-department relationships
  • 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” 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
  • 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

We offer:

  • Creative working in X-functional teams
  • Opportunities to work in Phase 3 studies and potential submissions
  • Open and appreciative corporate culture
  • Multicultural environment
  • 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. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if neccessary