Director, Biostatistics - Job ID: 1518

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

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 compounds/projects and manage study biostatistician(s) and/or consultant(s). The role reports to head of biostatistics and is based in Palo Alto, CA.

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
• 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
• Salary Range: $225-240k

A note to recruiters:

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs your ownership of these candidates will not be acknowledged.

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance  
• Mental Health resources
• Paid leave benefits for new parents