Director, Biostatistics - Job ID: DBPA

Ascendis Pharma is a dynamic fastgrowing global biopharmaceutical company with locations in Denmark Europe and the United States. Today were 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 bestinclass 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 role reports to VP of
Biostatistics and is based in Palo Alto.

Key Responsibilities

• Serves as a Lead study biostatistician and performs calculation of sample sizes authors statistical analysis plans and performs exploratory analysis.
• Provides statistical consultations on clinical study designs protocol writing analysis planning/execution clinical study report table/figure/listings statistical interpretations and regulatory submissions
• Providesleadershipand performstudydatareviewsduringclinicalstudiestoensure 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 processto meetdeliverablesand timelinesfor statisticaldataanalysis and reporting
• Manages biostatistics vendors identify potential risks and resolve issues with CROs
• Assists nonroutine projects as applicable in support of drug development activities

Salary Range: $225240K/year

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.

Knowledge Skills and Experience

• 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
• Demonstratedexperience inprovidingstatisticalinputanddirection into thedesign of clinicalstudiesdataanalyticapproachesinterpretationof findings and crafting of key messages

• 401(k) plan with company match
• Medical dental and vision plans
• Companyoffered Life and Accidental Death & Dismemberment (AD&D) insurance
• Companyprovided short and longterm 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

Required Experience:

Director