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Stellenangebote

Wir haben zum nächstmöglichen Zeitpunkt folgende Position zu besetzen:

(Senior) Biostatistician (m/f)

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 2-5 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

Wir bieten Ihnen:

  • Kreatives Arbeiten in X-functional Teams
  • Offene und wertschätzende Unternehmenskultur
  • Multikulturelles Umfeld
  • Arbeiten in einem attraktiven, hochwertig ausgestatteten Gebäude mit Betriebsrestaurant
  • Kostenfreie Sportangebote und Sprachkurse
Über Ihr Interesse und auf Ihre aussage­kräftigen Unter­lagen freuen wir uns! Bitte be­wer­ben Sie sich direkt über unser Karriere­portal www.morphosys.de/karriere. Wir bieten Ihnen nicht nur aus­ge­zeichnete Ent­wicklungs­möglich­keiten, sondern unter­stützen Sie von Anfang an – auch bei Ihrem Umzug.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg