Lead Biostatistician

Your activities

  • Lead biostatistics activities for clinical development from Phase I to Phase IV
  • Provide statistical inputs for study design, data collection, endpoint assessment, sample size and power calculation
  • Coordinate external statistician expert input when required
  • Proactively identify and resolve statistical issues in collaboration with the project team
  • Ensure clear and effective communication of statistical information and results internally and externally
  • Create statistical sections of clinical trial protocols, clinical study reports, and regulatory modules
  • Oversee the quality control and delivery of biostatistics vendor deliverables when statistical analyses are outsourced
  • Develop statistical analysis plans, analysis dataset specifications and programming
  • Develop tables, figures, and listings specifications and programming
  • Build and lead a cross-functional biostatistics team
  • Develop and implement quality assurance systems and procedures for internal and external biostatistics activities
  • Perspectively: Building up an internal team of statisticians (teamlead role)

Your background

  • PhD in biostatistics preferred
  • 5+ years of professional biostatistics experience, preferably in the pharmaceutical industry or CRO, with a strong asset in oncology clinical trials
  • Experience in designing clinical studies and developing clinical study protocols
  • Experience in managing frequentist and Bayesian biostatistical activities from concept to analysis programming and results interpretation
  • Solid background in developing Phase I to Phase III clinical study protocols and statistical analysis plans, including knowledge of new methodologies and designs such as basket studies, BOIN 1/2 dose finding design, interim analysis, etc.
  • Familiarity with CDISC, ICH-GCP, and other relevant regulations/guidelines
  • Strong programming skills in R and/or SAS for data formatting and analysis
  • Experience interacting with regulatory authorities
  • Demonstrated ability to lead complex scientific discussions, synthesize information clearly, and communicate effectively both orally and in writing
  • Demonstrated leadership experience, with the ability to work in a medium-sized company with a matrix environment
  • Professional proficiency in both spoken and written English

Your benefits

  • Family environment with plenty of room for development and creativity
  • Flexible working hours with working time recording and possibility to reduce overtime
  • High work-life balance, in particular good compatibility of family and career
  • Possibility to work almost exclusively remotely
  • Above-average compensation with many additional benefits (Christmas bonus, shares, company pension plan, training budget, etc.)
  • Possibility to build up and lead an internal team
Gender note

For reasons of better readability the language forms masculine, feminine and diverse (m/f/*) are used simultaneously. All references to persons apply equally to all genders.

Type of contract

Permanent Position




Medical Affairs




Entry date






Capacity (FTE)


Your contact person
Karoline Gutensohn

Executive Recruiting Managerin


We are looking forward to your application!

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*Nicht das Richtige für Sie?

Kein Problem! Kein Problem! Jetzt in einer Minute einfach initativ bewerben und zu passenden Jobangeboten kontaktiert werden!