Director Biostatistics - Global Biopharma (remote)

Proclinical are recruiting for a Director Biostatistics - Global Biopharma to join a biotech organisation. This role is on a permanent basis and is located in Frankfurt with the ability to work remotely from home.

Responsibilities:

• Monitor outsourced statistical CRO actions and deliverables guaranteeing highest quality.
• You will develop, execute and improve statistical procedures and standards.
• Assist with and contribute to the development of divisional methods.
• Engage with international regulatory authorities.
• Offer statistical contributions to clinical development plans, clinical study protocols, clinical study reports, regulatory proposal documents, and publications guaranteeing precise deliverables.
• Serve as a representative for statistics in cross-functional project and study teams within various projects.
• Conduct sample size calculations and statistical analysis, as well as develop statistical analysis plans and guide TLF development.
• The ideal candidate will validate analysis outcomes.

Key Skills and Requirements:

• Educated to an advanced degree level in a statistics or biostatistics field.
• Demonstrable experience working within a pharmaceutical organisation and/or CRO involving proposal involvement.
• Know-how of clinical stud designs, statistical strategies adaptive designs, regulatory guidelines such as ICH, FDA, EMA, and statistical software such as SAS, EAST, and R.
• Conscious of the bigger picture with a focus on quality, novelty and the ability to resolve issues.
• Ideally possess prior involvement in clinical study designs within cell gene therapies such as CAR-T, iNEST, etc.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-HH1

#Biometrics