Posted 4 months ago
(Senior) Specialist, Statistical Programmer
AI Summary
Develops and validates SDTM datasets using CDISC standards to support clinical data analysis and regulatory submissions for pharmaceutical trials.
About this role
Are you passionate about statistical programming? Do you have experience within Clinical trials and CDISC standards?
If so, now is your chance to join Ascendis Pharma as our new Specialist or Senior Specialist Statistical Programmer.
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 portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
We are seeking a passionate Statistical Programmer to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in development and evolution of modern, metadata-driven SDTM programming to support clinical data analysis. 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 Hub Bravo team consisting of 16 colleagues, and report directly to Claus Stenberg, Director, Head of Statistical Programming Hub Bravo You will be based in Hellerup
Your key responsibilities will be:
- Participating in the SDTM programming group, contributing to planning, development, and continuous improvement of SDTM deliverables
- Performing statistical programming activities to support clinical data analysis and reporting
- Collaborating cross-functionally with international colleagues in a dynamic and fast-paced organization
Qualifications and Skills:
You hold a relevant academic degree, preferably a Master’s or PhD, in statistics, mathematics, computer science, engineering, life sciences, or a related field – and 5 years of experience working on clinical trials within the pharmaceutical and biotechnology industry, using SAS and/or R.
Furthermore, you have:
- Experience with the development and validation of SDTM datasets, including implementation of CDISC SDTM standards
- Solid knowledge of regulatory submission requirements and standards, including CDISC SDTM, ADaM, Define-XML, ADRG, SDRG, and annotated CRFs
- Understanding of metadata-driven statistical programming approaches
- Familiarity with Python
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.
To succeed in this role, we also expect you to:
- Demonstrate strong attention to detail and a quality-focused mindset, ensuring inspection-ready deliverables
- Communicate clearly and effectively with both technical and non-technical stakeholders
- Take ownership of tasks and drive deliverables independently while maintaining alignment with project goals
Travel: 10days per year.
Office: Ascendis Pharma, Tuborg Boulevard 12, 2900 Hellerup
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 Claus Stenberg, Director, phone +45 21 68 18 59 and e-mail: csg@ascendispharma.com
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.
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