Head of Biometrics

vor 1 Monat


Garching bei München, Deutschland ITM Isotope Technologies Munich SE Vollzeit

ITM is a privately owned biotechnology and radio­pharma­ceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radio­pharma­ceuticals and radio­isotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuro­endocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radio­nuclide Therapies in Precision Oncology. The head­quarters are located in the heart of the research center of the Technical University of Munich (TUM).

We would like to fill the following permanent vacancy in a hybrid or remote-based working model in Garching as soon as possible

Head of Biometrics (f/m/d)

  • Create, lead, mentor, and develop a team of statisticians, data managers, and programmers and foster a collaborative and innovative environment
  • Develop, align and implement the strategic vision for the Biometrics department in accordance with overall company goals and regulatory requirements
  • Provide statistical leadership in the design of clinical development plans and protocols and plan long-term solution to data internalisation and management / storage / archiving
  • Oversee the planning and execution of all statistical and data management activities for clinical trials, RWE, non-clinical research and other R&D activities
  • Hands-on activities as statistician on selected projects and ensure accurate, high quality and timely delivery of statistical analyses and data management outputs
  • Ensure compliance with all relevant regulatory guidelines and lead the preparation and review of statistical sections for regulatory submissions
  • Communicate complex statistical concepts and results to non-statisticians from a variety of different departments
  • Drive continuous improvement and innovation within the team and department
  • PhD or Master's degree in Statistics, Biostatistics, Mathematics, or a related field
  • Ideally a minimum of ten years of experience in biostatistics and data management within the pharmaceutical or biotechnology industry
  • Proven track record of leading biometrics teams and managing complex projects in oncology indications
  • Extensive experience with clinical trial design, analysis, and regulatory submissions
  • Extensive experience with health authority interactions, including FDA meetings
  • Strong leadership and team management skills
  • Excellent statistical programming skills (e.g., SAS, R)
  • Strong analytical and problem-solving abilities
  • Excellent communication and interpersonal skills
  • Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
  • An open working atmosphere in an international corporate culture with short communication channels
  • Comprehensive onboarding programme
  • Flexible working hours with home office options
  • Attractive special payments
  • Just a good salary? Not with us We also offer you
    • Employee participation programme
    • Job bike or subsidised job ticket
    • Above-average contribution to the company pension scheme
    • Individually tailored further training programme (including German or English courses)
    • Health promotion programmes (e.g. subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)

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