Associate Director, Biostatistics - Remote

Overview

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 role reports to VP of Biostatistics.

In Short

• 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.
• Provides leadership and performs study data reviews during clinical studies to ensure that clinical studies are on 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, identifies potential risks and resolves issues with CROs.
• Assists non-routine projects as applicable in support of drug development activities.

Requirements

• Proven experience in biostatistics and clinical trial methodology.
• Strong knowledge of statistical software and programming.
• Excellent communication and leadership skills.
• Ability to work collaboratively in a team environment.
• Experience with regulatory submissions is a plus.

Benefits

• Dynamic workplace for professional growth.
• Opportunity to work on innovative drug development projects.
• Supportive company culture focused on science and patient care.
• Competitive salary and benefits package.