Biostatistician - Senior Specialist/Associate Director

<p><em>Are you passionate about&nbsp;applying your (bio) statistical&nbsp;expertise? Do you have experience&nbsp;within&nbsp;clinical trials?&nbsp;</em></p><p><em>If so, now is your chance to join Ascendis Pharma as our new&nbsp;Senior Specialist/Associate Director&nbsp;within Biostatistics.&nbsp;</em></p><p>Ascendis Pharma&nbsp;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&nbsp;TransCon® technology platform to fulfill our mission of developing new therapies that&nbsp;demonstrate&nbsp;best-in-class potential to address unmet medical needs.&nbsp;&nbsp;</p><p>At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and&nbsp;additional&nbsp;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&nbsp;TransCon-based products in other therapeutic areas and markets.&nbsp;&nbsp;</p><p>We are seeking&nbsp;a passionate&nbsp;biostatistician&nbsp;to join our growing team. As a key member of&nbsp;the&nbsp;Ascendis Pharma&nbsp;team, you will play a crucial role in:&nbsp;</p><ul><li>Providing biostatistical leadership in cross-functional teams&nbsp;</li><li>Providing&nbsp;statistical&nbsp;input&nbsp;on clinical&nbsp;trial&nbsp;designs,&nbsp;writing of&nbsp;protocol, analysis planning,&nbsp;execution&nbsp;and&nbsp;interpretations.&nbsp;Initiating&nbsp;and driving&nbsp;innovation by implementing relevant designs in the support of program strategy.</li><li>Contributing&nbsp;to&nbsp;non-routine projects as applicable in support of drug development activities&nbsp;for instance&nbsp;internal and external scientific reports, presentations, and publications&nbsp;</li><li>Providing&nbsp;statistical input for regulatory submissions including response to questions from regulatory agencies and institutional review boards&nbsp;</li></ul><p>This is an exciting opportunity to work in a fast-paced environment,&nbsp;collaborate&nbsp;with cross-functional, global teams working together to achieve extraordinary results.&nbsp;</p><p>You&nbsp;will be joining the&nbsp;Biostatistics&nbsp;team&nbsp;in Hellerup&nbsp;consisting of&nbsp;4&nbsp;colleagues, and&nbsp;report directly to&nbsp;Helle Hartvig,&nbsp;Director&nbsp;Biostatistics&nbsp;who is based in&nbsp;Hellerup.&nbsp;You will be&nbsp;based&nbsp;in&nbsp;Hellerup.&nbsp;&nbsp;</p><p>Your key responsibilities will be:&nbsp;</p><ul><li>Serving&nbsp;as&nbsp;lead&nbsp;trial&nbsp;biostatistician and performing&nbsp;calculation of sample sizes, authoring&nbsp;statistical analysis&nbsp;plans&nbsp;and performing&nbsp;exploratory analysis.&nbsp;&nbsp;</li><li>Collaborating&nbsp;with cross functions including statistical programmers, biostatisticians, clinical development, medical writing,&nbsp;and regulatory,&nbsp;to ensure&nbsp;deliverables and timelines for statistical data analysis and reporting&nbsp;are met&nbsp;</li></ul><p>Qualifications and Skills:&nbsp;</p><p>You hold a relevant academic degree - preferably a&nbsp;Master's&nbsp;or PhD—in statistics, mathematics, or&nbsp;related field&nbsp;- along with at least&nbsp;7&nbsp;years of experience in the pharmaceutical, biotechnology, or medical device industry.&nbsp;</p><p>Furthermore,&nbsp;it is also an advantage to&nbsp;have:&nbsp;</p><ul><li>Submission experience (NDA, BLA and/or MAA)&nbsp;&nbsp;</li><li>Good ability to translate clinical&nbsp;trial&nbsp;designs into statistical practice and communicate the use of statistics to non-statisticians.&nbsp;</li></ul><p>Key competencies:&nbsp;</p><p>You are&nbsp;a strong team&nbsp;player, analytical, and have a can-do attitude.&nbsp;&nbsp;</p><p>You&nbsp;possess&nbsp;an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.&nbsp;&nbsp;&nbsp;&nbsp;</p><p>Furthermore, the position requires flexibility and the ability to work some overlapping hours with colleagues&nbsp;based&nbsp;the US.&nbsp;</p><p>To succeed in this role, we also expect you to&nbsp;have:</p><ul><li>Excellent interpersonal skills and strong English communication abilities&nbsp;</li><li>A high degree of personal accountability and a results-oriented mindset&nbsp;</li></ul><p>Travel:&nbsp;5-10&nbsp;days&nbsp;per year.&nbsp;</p><p>Office:&nbsp;Tuborg Boulevard,&nbsp;Hellerup,&nbsp;Denmark&nbsp;&nbsp;&nbsp;</p><p>Apply now.&nbsp;</p><p>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.   &nbsp;</p><p>To ensure your application is reviewed, please&nbsp;submit&nbsp;it through the specified platform - applications sent by email or other channels will not be evaluated. &nbsp;</p><p>For more details&nbsp;about the position or the company, please contact&nbsp;Helle&nbsp;Hartvig,&nbsp;Director, Biostatistics&nbsp;M&nbsp;+ 45 61 29 29 06 or&nbsp;<a href="mailto:hvh@ascendispharma.com" target="_blank" rel="nofollow noreferrer noopener" class="external">hvh@ascendispharma.com</a>.&nbsp;</p><p>You can learn more about Ascendis by visiting&nbsp;our website&nbsp;<a href="http://www.ascendispharma.com/" target="_blank" rel="nofollow noreferrer noopener" class="external">www.ascendispharma.com</a>&nbsp;&nbsp;&nbsp;</p><p>Applications&nbsp;must be&nbsp;submitted&nbsp;in English and will be treated confidentially.&nbsp;</p><p>&nbsp;</p><p>A note to recruiters:&nbsp;&nbsp;</p><p>We do not allow external search party solicitation.&nbsp;&nbsp;Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.&nbsp;&nbsp;If this occurs, your ownership of these candidates will not be acknowledged.&nbsp;</p>