Biostatistician - Senior Specialist/Associate Director

Are you passionate about applying your (bio) statistical expertise? Do you have experience within clinical trials?

If so, now is your chance to join Ascendis Pharma as our new Senior Specialist/Associate Director within Biostatistics.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate biostatistician to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in:

• Providing biostatistical leadership in cross-functional teams
• Providing statistical input on clinical trial designs, writing of protocol, analysis planning, execution and interpretations. Initiating and driving innovation by implementing relevant designs in the support of program strategy.
• Contributing to non-routine projects as applicable in support of drug development activities for instance internal and external scientific reports, presentations, and publications
• Providing statistical input for regulatory submissions including response to questions from regulatory agencies and institutional review boards

This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Biostatistics team in Hellerup consisting of 4 colleagues, and report directly to Helle Hartvig, Director Biostatistics who is based in Hellerup. You will be based in Hellerup.

Your key responsibilities will be:

• Serving as lead trial biostatistician and performing calculation of sample sizes, authoring statistical analysis plans and performing exploratory analysis.
• Collaborating with cross functions including statistical programmers, biostatisticians, clinical development, medical writing, and regulatory, to ensure deliverables and timelines for statistical data analysis and reporting are met

Qualifications and Skills:

You hold a relevant academic degree - preferably a Master's or PhD—in statistics, mathematics, or related field - along with at least 7 years of experience in the pharmaceutical, biotechnology, or medical device industry.

Furthermore, it is also an advantage to have:

• Submission experience (NDA, BLA and/or MAA)
• Good ability to translate clinical trial designs into statistical practice and communicate the use of statistics to non-statisticians.

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

Furthermore, the position requires flexibility and the ability to work some overlapping hours with colleagues based the US.

To succeed in this role, we also expect you to have:

• Excellent interpersonal skills and strong English communication abilities
• A high degree of personal accountability and a results-oriented mindset

Travel: 5-10 days per year.

Office: Tuborg Boulevard, Hellerup, Denmark

Apply now.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.   

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated. 

For more details about the position or the company, please contact Helle Hartvig, Director, Biostatistics M + 45 61 29 29 06 or [email protected].

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR 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.