Statistician (f/m/x)

vor 4 Wochen

Munich, Deutschland Daiichi Sankyo Europe GmbH Vollzeit
Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our European Headquarter in Munich or other affiliates in Europe we are looking for aManager Statistical Programming (m/f/x)The position:
  • The position holder will manage, with direction, end-to-end delivery of Statistical Programming ser-vices for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
  • The position holder will partner with internal and external stakeholders to optimize Statistical Pro-gramming technology, processes, and standards.
  • The position will have a working knowledge of Statistical Programming applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
Roles & responsibilities:
  • Study level statistical activities
    • Responsible, with supervision, for study activities assigned to Statistical Programming including but not exclusive to SAPs and TFL shells review from a programming perspective, contribute to develop specifications for SDTMs and ADaM datasets, contribute to develop and validate SAS programs to create SDTM and ADaM datasets and TFLs, demonstrate knowledge with XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
    • Ensure timely and accurate completion of Statistical Programming deliverables
    • Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities
    • Must comply with international regulations and maintain inspection readiness
    • Ensure inspection readiness as well as prepare potential audits linked to assigned studies
  • Vendor Oversight
    • With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other rele-vant guidelines
    • Participates in drafting request for proposal for CRO selection. Reviews base-line budget and time-lines. Contributes to budget management and activities across the project duration
    • Participate in meeting or teleconferences with vendors by providing advice
  • Operational Excellence Innovation
    • Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions
    • Maintains current knowledge of industry best practice in Statistical Programming methodology
Any other duties deemed pertinent to the needs of the business. Professional experience & education:
  • Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; master’s degree in bio/statistics preferred
  • At least 2 years of experience supporting drug development and/or post marketing in clinical re-search, Pharmaceutical, CRO or Medical Device setting
  • Experience in oncology Therapeutic Area and/or in late phase projects is an advantage
  • Competencies and Generic Skills
  • Excellent English language skills
  • Good understanding of GCP and GDPR principles
  • Good communication skills, both oral and written, in explaining in simple terms complex concepts
  • Advanced working knowledge all SAS language, procedures and options commonly used in clinical tri-al reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. Knowledge of SAS Enterprise Guide and/or SAS Studio is recommended but not required
  • Previous experience supporting SAS macro and/or system utility development is preferred
  • Solid knowledge of new advanced statistical methods using SAS
  • R knowledge is highly recommended but not required
  • Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clini-cal Research.
  • Fundamental negotiation and project management skills
  • Ability and interest to work remotely with worldwide team members across cultures and time zones
We are looking for a flexible, stress-resistant team player who can work reliably also under time pressure. Your thinking is analytical and structured; your work style shows a high level of responsibility and quality consciousness. If you in addition like to work in a multi-cultural and international cooperation, then you are the right person for us.Why work with us?
  • Excellent Benefits
  • Work-Life-Balance
  • Growth and Development
  • Health and Wellbeing Support

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