Statistical Programmer

Responsibilities

• Participate in the SDTM programming group, contributing to the planning, development, and continuous improvement of SDTM deliverables
• Perform statistical programming activities to support clinical data analysis and reporting
• Collaborate cross-functionally with international colleagues in a dynamic, fast-paced organization
• Develop and evolve modern, metadata-driven SDTM programming to support clinical data analysis

Requirements

• Master's or PhD in statistics, mathematics, computer science, engineering, life sciences, or a related field
• 5 years of experience working on clinical trials within the pharmaceutical or biotechnology industry
• Proficiency in SAS and/or R
• Experience with the development and validation of SDTM datasets and implementation of CDISC SDTM standards
• Solid knowledge of regulatory submission requirements and standards, including CDISC SDTM, ADaM, Define-XML, ADRG, and SDRG
• Understanding of metadata-driven statistical programming approaches
• Familiarity with Python

Preferred Qualifications

• Strong attention to detail and a quality-focused mindset for inspection-ready deliverables
• Ability to communicate effectively with both technical and non-technical stakeholders
• Entrepreneurial mindset with the ability to thrive in an informal, innovative environment

About the Company

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 apply our innovative TransCon® technology platform to develop new therapies that address unmet medical needs in Endocrinology and Rare Diseases.