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.
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.
- 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.
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.