Associate Director Biostatistics

Vor 5 Tagen

Mainz, Deutschland Proclinical Vollzeit

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

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**Responsibilities**:

- Conduct statistical analysis and validate analysis outcomes.
- Monitor outsourced statistical CRO actions and deliverables, guaranteeing hight quality.
- You will develop, execute and improve statistical procedures and standards.
- Serve as a representative for statistics in cross-functional project and study teams in various projects.
- Offer tactical contributions to clinical development pans, clinical study protocols, clinical study reports, regulatory proposal documents, and publications assuring precise deliverables.
- Assist and partake in the development of divisional methods.
- You will engage with international regulatory authorities.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in a statistics or biostatistics field.
- At least 5 years (MS degree) or at least 3 years (PhD) of experience working in a pharmaceutical and/or CRO which involves proposal familiarity.
- Know-how of clinical study designs. Statistical strategies, adaptive designs, regulatory guidelines such as ICH, FDA, EMA, etc., as well as statistical software such as SAS, EAST and R.
- Conscious of the bigger picture.
- A high attention to detail.
- Able to resolve issues.
- Past involvement working with clinical study designs in oncology or infectious illnesses.

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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