Senior Manager, Biostatistics - JOB ID: 1139

The individual in this position will provide the 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 role reports to compound lead statistician.

Key Responsibilities

• Biostatistics study lead, with accountability of biostatistics deliverables, including biostatistics support to clinical development plans, clinical study designs, clinical protocols, analysis planning/execution, and clinical study report table/figure/listings and statistical interpretations
• Contribute to internal and external scientific reports, presentations, and publication activities
• Ensure the quality of statistical input and show the ability to integrate expertise across Biostatistics components internally and externally
• Collaborates with cross functional peers in DK and US to meet deliverables and timelines for statistical data analysis and reporting
• Manages biostatistics vendors, identify potential risks and resolve potential issues with CROs
• Assists on non-routine projects as applicable in support of drug development activities

Requirements

• PhD in biostatistics, statistics or equivalent, with 4+ years (or MS with 6+ years) of relevant experience in the biotechnology or pharmaceutical industry
• Excellent interpersonal and communication skills
• Ability to work proactively while handling multiple deliverables and short timelines
• Extensive knowledge of GCP, ICH guidelines, FDA regulations
• Strong knowledge and skills of programming in SAS and solid understanding of CDISC SDTM and ADAM models and standards
• Ability to examine issues from various perspectives and apply appropriate concepts to address situations
• Demonstrated experience in providing statistical input and direction into the design of clinical studies, data analytic approaches, interpretation of findings and crafting of key messages.
  • 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: $170-190K/year

Benefits

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