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Sr./Principal CMC Statistician

Sr./Principal CMC Statistician in a fast-growing biotech company.

Ascendis Pharma, a visionary and ambitious company, offers you an opportunity to become a major participant in the further development and expansion of the current clinical stage TransCon products as well as supporting commercial TransCon products.

As Sr./Principal CMC Statistician at Ascendis Pharma the main success criteria is to help establish the statistical discipline, create a good understanding of deliverables, communicate statistical results to the CMC and PS project team members and to be able to establish a close and high-standard cooperation with the CMC and PS project teams within Ascendis Pharma as well as with the CMOs used by Ascendis Phama.

It is an unique opportunity for the right candidate to gain influence and develop the statistical area within CMC. Moreover, the candidate is exptected to operate on a global level as the position involves close cooperation with the development and support team in Heidelberg in Germany together with the clinical statisticians in Palo Alto in the US.

You report directly to the VP, CMC Pharmaceutical & Device Development and will be part of a very dedicated and experienced team.

Your main responsibilites are:

  • Set the strategy for data handling including strategy for statistical model for calculation of e.g. specification limits, design of experiments, control charts and shelf-life
  • Support CMC/PS development, validation studies as well as post-approval activities
  • Support complex investigations, deviations and changes
  • CMC development studies will cover the entire CMC value chain from starting matrials, intermediates, drug substance, drug product, device to analytical methods
  • Calculations of specifications within the entire CMC value chain
  • Contribute to the writing of relevant regulatory quality documentation
  • Contribute with statistical strategy and calculations to responses during Q&A
  • Report on project progress via line management and project review meetings
  • Main responsible for statistical tools used at Ascendis Pharma (SAS JMP) and assuring training of CMC project team members in using the tool

You hold a relevant academic degree – preferably a Master of Science in Statistics. A PhD is preferred but not a demand.

The following qualifications are preferred:

  • 5 – 15 years of statistical experience preferably within the CMC field
  • Interest in other scientific disciplines of the CMC value chain
  • Knowledge within regulatory requirements for pharmaceuticals

You are proficient in English at a professional level, both written and spoken, and you master MS Office as well as relevant statistical programming tools.

You have a high level of drive, ambition, and passion. You take initiative, are persistent, pay a high level of attention to details and you are goal-oriented. You are comfortable with a risk-based approach to decision-making in a dynamic environment in which priorities and drivers can change rapidly. You are flexible, pragmatic with an open and communicative approach and have the ability to develop effective working relationships with employees at all levels.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work together with highly skilled and experienced colleagues to advance the exciting product pipeline.

Travelling: 5 – 10 days/ year

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be submitted in English and are treated confidentially.

Unique Human Capital A/S
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