Statistical Specialist

Join Our Team as a Statistical Specialist at Ascendis Pharma

Are you passionate about science and drug development? Do you want to make a an impact in a leading and fast-growing biotech company? Join the Research and Product Development organization at Ascendis Pharma, where your work can help transform patient lives worldwide.

The role

As our new Statistical Specialist, you will play a pivotal role in providing statistical support to our CMC (Chemistry, Manufacturing, and Controls) and Product Supply organizations. You will work closely with both internal project teams and external partners to define deliverables and communicate statistical results. Your contributions will be critical in maintaining our position at the forefront of therapeutic innovation as we expand our pipeline.

Your key responsibilities will be:

• Serve as a strategic partner to other teams, offering project-specific support on specifications justification, shelf-life analysis, comparability assessments, and investigational analysis.
• Consult with internal stakeholders, addressing research, manufacturing, or quality-related questions with appropriate statistical tools.
• Contribute to regulatory filings by authoring and reviewing statistical content and supporting interactions with health authorities.
• Act as a subject matter expert for statistical aspects throughout the entire lifecycle of a pharmaceutical product, including development, qualification, validation, and investigations.
• Develop and implement statistical applications for routine data analysis tasks.

You will join a dedicated team of five colleagues within a department that supports and coordinates cross-functional activities in product development. You will work under the guidance of our experienced Senior Principal Statistician and report directly to the Vice President for Product Development Projects.

Your Qualifications:

• A relevant academic degree in statistics, mathematics, data science, engineering, or a similar field.
• 5-10 years of experience with applied statistics.
• Strong knowledge of statistical methods such as Design of Experiments (DOE), regression modeling, variance component analysis, multivariate analysis, process capability, and control charts.
• Advanced skills using one or more statistical packages or languages, with knowledge of JMP preferred.
• Experience in the CMC field and familiarity with regulatory requirements for pharmaceuticals are preferred.

Key competencies:

As a person you are analytical and science-driven with a strong attention to detail. You are flexible and adaptable with a “can do” attitude. You are pragmatic and communicative, capable of developing effective working relationships across different areas. Finally, you are willing to take on responsibilities and work independently.

Additional Information:

Travel: 10-20 days per year.

Office Location: Our office is located in the beautiful Tuborg Havn in Hellerup, offering stunning views of the harbor, canals, and sea.

If you are ready to make a difference in a cutting-edge biopharmaceutical company, apply now and join us at Ascendis Pharma.

For more details about the position or the company, please contact Peter Thyregod on + 45 30962956 or PTD@ascendispharma.com or visit out website www.ascendispharma.com

All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.

Last updated on Apr 19, 2024