Principal Biostatistician

Ascendis Pharma

Ascendis Pharma

Data Science
2900 Hellerup, Denmark
Posted on Thursday, October 12, 2023

Are you an ambitious team-player, passionate about biostatistics, and want to play a key role in the success of our exciting portfolio within endocrinology? Then this may be a great opportunity for you.

The role

As our new Principal Biostatistician, you will be a key player in advancing Ascendis Pharma’s product pipeline and play a key role in building up a biometrics team. You will be responsible for contributing strategic, scientific, and statistical insight so that the priorities and objectives of Ascendis Pharma are achieved.

Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company headquartered in Hellerup where innovation is always appreciated. We offer room to grow and freedom to take responsibility so that you can make a difference for patients. As a member of our global Biometrics team, you will work with highly skilled and passionate colleagues around the world to advance our exciting product pipeline.

Responsibilities

  • Provide biostatistical leadership in cross-functional teams
  • Contribute to clinical development plans, clinical study designs, clinical protocols and data reviews
  • Initiate and drive innovation by implementing relevant designs in the support of program strategy
  • Plan and execute analyses to produce clinical study report table/figure/listings
  • Provide statistical interpretations and act as Biostatistical subject matter expert
  • Provide statistical input for regulatory submissions including response to questions from regulatory agencies and institutional review boards
  • Contribute to internal and external scientific reports, presentations, and publications
  • Collaborate with cross-functional peers in the US to facilitate and optimize clinical development
  • Supervision of biostatistics vendors and consultants
  • Ad hoc assistance to colleagues throughout Ascendis Pharma

Your professional qualifications

  • Master’s degree in biostatistics, statistics, mathematics, or related field
  • Minimum 8-10 years relevant experience in the biotechnology or pharmaceutical industry
  • Excellent interpersonal and English communication skills
  • Strong knowledge and skills in SAS and/or R
  • Experience with CDISC SDTM and ADaM models and standards

It is also an advantage to have:

  • NDA, BLA and/or MAA experience
  • Ability to translate clinical study designs into statistical practice and communicate the use of statistics to non-statisticians.

Personal skills

As a person, you are a pro-active team player and a strong communicator who thrives in a complex, fast-paced, expanding organization. You are individually accountable and result oriented.

Travel: approx. 10 days per year.

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

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