Director, Biostatistics - Job ID: 1812

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 individual 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 biostatistics and is based in US.

Key Responsibilities

• Biostatistics project/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
• Provide statistical input for regulatory submissions; respond to statistical questions raised by regulatory agencies and institutional review boards
• 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
• Research and apply new statistical procedures as needed. Initiate and drive innovation by implementing innovative and relevant designs in the support of program strategy
• 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 potential issues with CROs
• Manages study biostatistician(s) and/or consultant(s)
• Assists on non-routine projects as applicable in support of drug development activities

Requirements

• PhD in biostatistics, statistics or equivalent, with at least 10 years (or MS with at least 13 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
• Ability to translate clinical study designs into statistical practice and educate study team members in the use of statistics
• Ability to influence and communicate across functions
• 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

The estimated salary range for this position is $235-250K.  Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location.  This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package. 

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