Director Biostatistics

Proclinical are recruiting a Director Biostatistics for a biotech establishment. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. The client is focused on improving the health of many.

**Responsibilities**:

- Supervise outsourced statistical CRO actions and deliverables guaranteeing highest quality.
- Serve as a representative for statistics in cross-functional project and study teams in various projects.
- You will engage with international regulatory authorities.
- Conduct sample size calculations, develop statistical analysis plans and guide TFL development.
- Assist and contribute to the development of divisional tactics.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in statistics or biostatistics.
- At least 4 years (6 years if educated to a masters degree level) in a pharmaceutical organisation and/or CRO which involves submission acquaintance.
- Know-how of clinical study designs, statistical methods, adaptive designs, regulatory guidelines such as ICH, FDA, EMA, etc, and statistical software such as SAS, EAST and R.
- Conscious of the bigger picture, solid orientation to quality, novelty and solution focused thinking.
- Ideally familiar with clinical study designs in cell gene therapies such as CAR-T, iNEST, etc.

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.

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