Director, Medical Affairs Statistical Sciences, Biometrics - Job ID: 1564

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.

This role will interact with regulatory agencies on matters related to the data for clinical programs and/or trials. Utilizing statistical methods to conduct health economics and outcomes research (HEOR) studies to assess the cost-effectiveness of a product.

The Director ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

The preferred location for this position is in our office in Palo Alto, California. Remote work will be considered for the right applicant.

Main Tasks:

• Ensures the timeliness and quality of statistical deliverables for clinical trial and registry results, exploratory and meta-analyses, publication activities, and scientific presentations.
• Assures statistical integrity, adequacy and accuracy of statistical analysis and result interpretation.
• Develops solutions to statistical and data analysis issues for clinical issues for regulatory, medical affairs, market access, and commercial teams. Communicates solutions cross-functionally.
• Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
• Authors and manages the implementation of statistical analysis plans, defining data analysis strategies, interpreting the result findings, and crafting and communicating key messages to internal audiences and selected key external stakeholders.
• Defines data analysis and mining strategies for natural history databases.
• Participates in vendor evaluation, selection, and management.
• Performs other tasks and assignments as needed and specified by management.

• Advanced degree in Statistics or a related statistical discipline and a minimum of 10 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
• Experienced in the application of causal inference models to clinical trial and RWE data.
• Publication experience and/or experience of presenting at external meetings.
• Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies and key opinion leaders.
• Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry.
• Hands-on statistical programming skills using R and/or SAS.
• Ability to influence in cross-functional team settings without direct authority.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Special knowledge or skills and/or licenses or certificates preferred.
• Excellent understanding of applicable regulatory requirements and guidance documents.
• Prior BLA, NDA and/or MAA experience is highly desirable.

A note to recruiters:

If this occurs your ownership of these candidates will not be acknowledged.

• 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