Associate Director Biostatistics

hace 1 mes


Barcelona, España Proclinical A tiempo completo

Proclinical are recruiting for an individual to join a pharmaceutical corporation. This role is on a permanent basis. The opening position is for a Biostatistics Associate Director.

**Responsibilities**:

- Oversee project progress and guarantee proper resource allocation for project deliverables against objectives and timelines.
- You will leverage standardisation to maximise international data integration and interpretability.
- Guarantee precise, statistically valid deliverables which involves protocols, statistical analysis plans, study reports, manuscripts, and regulatory proposal documents.
- Arrange accomplishment of statistical deliverables and milestones in cooperation with other functions.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in a statistical/biostatistics discipline with at least 7 years of pertinent pharmaceutical experience with a PhD, or at least 10 years of pertinent pharmaceutical experience with a MSc.
- Expertise of statistical strategy in design and analysis of clinical trials which involves Bayesian modelling and adaptive design.
- Knowledge of regulatory needs linking to clinical development of drugs and biologics.
- Familiarity with BLA/NDA which involves eCTD proposals.
- Know-how of major statistical software programs which involves SAS.
- Expertise of CDISC needs for SDTM and ADaM.
- Communication skills both verbally and in writing.
- An organised individual who works well under pressure.

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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