Director of 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.

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 perform study data reviews during clinical studies to ensure that clinical studies are on course 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.
• Assists non-routine projects as applicable in support of drug development activities.

Requirements

• Experience in biostatistics and clinical research.
• Strong knowledge of statistical methods and regulatory requirements.
• Excellent leadership and communication skills.
• Ability to collaborate effectively with cross-functional teams.
• Experience managing external vendors and CROs.

Benefits

• Dynamic workplace for growth and development.
• Engaging culture focused on science and patients.
• Opportunity to work on innovative drug development projects.