Director Biostatistics

vor 2 Wochen

Frankfurt am Main, Deutschland Proclinical Vollzeit

Proclinical are recruiting a Director Biostatistics - Germany for a biotech consultancy. This role is on a permanent basis with the ability to work remotely from anywhere in Germany.

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**Responsibilities**:

- Supervise outsourced statistical CRO actions and deliverables, guaranteeing highest quality.
- Assist with and partake in the development of divisional methods.
- Serve as a representative in cross-functional project and study teams in various projects.
- Offer statistical contributions to clinical development plans, clinical study protocols, clinical study reports, regulatory proposal documents, and publications guaranteeing precise deliverables.
- Conduct sample size calculations, develop statistical analysis plans, and guide the TLF development.
- Other duties may be assigned to the role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in a statistics or biostatistics field.
- At least 4 years (PhD), or at least 6 years (MS degree) of experience working in a pharmaceutical and/or CRO along with proposal familiarity.
- Know-how of clinical study designs, regulatory guidelines, such as ICH, FDA, EMA, etc., statistical strategies and statistical software such as SAS, EAST, and R.
- Conscious of the bigger picture.
- A high attention to detail with the ability to resolve issues.
- Ideally acquainted with clinical study designs in cell gene therapies, such a 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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