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Lead Biostatistician

Project-ID: 1728
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Ihr Aufgabengebiet

  • 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)

Ihr Hintergrund

  • 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

Ihre 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-Hinweis

Aus Gründen der besseren Lesbarkeit wird auf die gleichzeitige Verwendung der Sprachformen männlich, weiblich und divers (m/w/d) verzichtet. Sämtliche Personenbezeichnungen gelten gleichermaßen für alle Geschlechter.

Vertragsart

Festanstellung

Branche

Pharmaceuticals

Fachbereich

Medical Affairs

Ort

Remote

Deutschland

Starttermin

asap

Dauer

Unbefristet

Remote

ja

Auslastung (FTE)

1

Ihr Ansprechpartner
hexagon_portrait_6
Karoline Gutensohn

Executive Recruiting Managerin

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