Statistical Programmer

Ascendis Pharma; Gentofte Kommune; On-site; DKK 750,000 - 1,100,000; Full time

Job summary

Ascendis Pharma is seeking a Senior/Specialist Statistical Programmer to join the biometrics team at our Hellerup headquarters. You will contribute to the planning, development and continuous improvement of SDTM deliverables, and develop metadata-driven programming solutions to support clinical trials.

You will review trial data, ensure quality, and collaborate across international teams. A Master's or PhD in a related field with 5+ years SAS experience in clinical trials is required.

Qualifications

• Masters or PhD in statistics, mathematics, computer science, engineering, life sciences, or related field.
• 5+ years of SAS experience working on clinical trials in pharma/biotech/medical devices.

Responsibilities

• Contribute to planning, development, and continuous improvement of SDTM deliverables.
• Develop (automated) programming solutions and metadata-driven approaches.
• Optimize metadata and their application.
• Review clinical trial data and specifications for high-quality deliverables.
• Support metadata validation and quality control.

Skills

SDTM programming

SAS

Clinical trials

Education

Master's or PhD in statistics/related field

Tools

SAS

Job description

Are you enthusiastic about statistical programming? Do you have experience applying SDTM to complex Clinical trial data?

If so, now is your chance to join Ascendis Pharma as our 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 Statistical Programmer to join our biometrics team. As a key member, you play a crucial role in development and evolution of progressive, 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 part of a team of 20 colleagues based in Hellerup.

Your key responsibilities will be:

• Contribute to planning, development, and continuous improvement of SDTM deliverables
• Develop (automated) programming solutions and metadata-driven approaches to support clinical trials
• Optimize metadata and their application
• Review clinical trial data and specifications to ensure high-quality deliverables
• Support metadata validation and quality control
• Collaborate 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 SAS experience working on clinical trials within the pharmaceutical/ biotechnology/medical device industry

Furthermore, you have:

• Experience with development and validation of SDTM datasets, including implementation of CDISC SDTM standards
• Solid knowledge of regulatory submission requirements and standards
• Interest in using AI as an integral part of all tasks

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

You thrive in an informal, open environment where innovation and change are key.

To succeed in this role, you should be:

• Detail-oriented
• Quality-focused to ensure inspection-ready deliverables
• An effective Communicate clearly and effectively with both technical and non-technical stakeholders
• Take ownership of tasks

Travel: 10 days per year.

For more details about the position or the company, please contact Claus Stenberg, Director, phone [phone], e-mail: [e-mail]

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

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