Description

The individual in this position will provide leadership, execution of biostatistics activities associated with drug development to ensure that development activities are consistently aligned with the priorities and objectives of Ascendis Pharma. The Director, Biostatistics, will be responsible for overseeing all biostatistics activities for assigned compound and manage study biostatistician(s) and/or consultant(s). The role reports to Head of Biometrics and is based in Palo Alto.

Key Responsibilities

  • Represents biostatistics project lead, with accountability of biostatistics deliverables, including biostatistics support of clinical development planning, clinical study designs, protocol writing, analysis planning/execution, clinical study report table/figure/listings, statistical interpretations, and regulatory submissions,
  • Provides leadership and perform study data reviews during clinical studies to ensure that clinical studies are in the right course as planned with proper checking of assumptions used for statistical analyses.
  • Collaborates with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting.
  • Manages biostatistics vendors, identify potential risks and resolve issues with CROs.
  • Manages study biostatistics(s) and/or consultant(s).
  • Assists non‐routine projects as applicable in support of drug development activities

Requirements

  • PhD in statistics or equivalent, with at least 10 years of relevant experience in biotechnology or pharmaceutical industry
  • Excellent interpersonal and communication skills both written and verbal
  • Extensive knowledge of GCP, ICH guidelines, FDA regulations
  • Strong knowledge and skills of programming in SAS.
  • Ability to examine issues from various perspectives and apply appropriate concepts to address situations.
    • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
    • Salary range: $225-255K/year

    Benefits

    • Medical insurance
    • Vision insurance
    • Dental insurance
    • 401(k)
    • Paid maternity leave
    • Paid paternity leave
    • Commuter benefits
    • Disability insurance