Biostatistician (m/f)

  • Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals) or Computer Sciences or comparable experience
  • At least 5 years of experience in biostatistics (incl. biostatistical programming) in the pharmaceutical / biotechnology industry
  • CDISC expertise (SDTM, ADaM, Define.XML)
  • Expertise in SAS programming / R programming as well as knowledge of medical terminology, Coding, SAE reconciliation preferable
  • Experience in biostatistics project management
  • Experience in oncology preferable
  • Comprehensive knowledge of ICH-GCP, FDA and EMA regulations
  • Oversee and manage biostatistical activities and provide support to sponsor / CRO teams (clinical research and translational medicine)
  • Oversee and provide planning to all biostatistical aspects of clinical trial protocols
  • Review clinical trial documents for biostatistical aspects
  • Oversee and manage the development, implementation and change management of biostatistical activities (i.e. statistical analysis plan, statistical data review, programming of and derived datasets, data listings, patient profiles and TLFs, clinical non-compliances, etc)
  • Oversee and validate biostatistical programme codes
  • Oversee and manage the development, implementation and change management of programming specifications for analysis datasets, pooled datasets and deliverables
  • Oversee and manage statistical programming of ISS/ISE and for requests from authorities
  • Oversee and manage biostatistical reporting of clinical trial data (i.e. DSUR, medical publications, clinical study report, etc)
  • Author biostatistics SOPs
  • Archive programme codes, data outputs and related documents

» Job description

Medigene AG
82152 Planegg-Martinsried