Associate Director Statistical Programming

vor 8 Monaten

Frankfurt am Main, Deutschland Proclinical Vollzeit

Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. The opening position that is currently available is for an Associate Director Statistical Programming.

**Responsibilities**:

- Assist with the development and execution of an international programming ecosystem to facilitate successful project deliverables.
- Contribute to the development and execution of the company's centralised data warehouse.
- Form novel solutions to standardise, automate and optimise effectiveness and quality to meet business requirements as well as regulatory needs.
- You will set up tools for effective verification of derived datasets such as SDTM and ADaM, and TLFs.
- Produce ad hoc datasets and TLFs on an ongoing basis.
- Write and evaluate programming specifications and validation.
- Other duties may be assigned.

**Key Skills and Requirements**:

- Educated to a degree or advanced degree level in a statistics, mathematics, computer science or similar field.
- Demonstrable experience within a pharmaceutical, CRO, or any other clinical research environment.
- Expertise on statistical programming within SAS which involves Base, macro, STAT, GRAPH. SQL, etc.
- Comprehension of FDA, EMA, ICH and international guidelines and regulations, as well as know-how of industry standards suitable for clinical study data and reporting on clinical trials, which involves CDISC standards.
- Consciousness of the drug development process from early
- to late-stage development and proposal.
- Knowledge of the needs and technology necessary for assisting with electronic proposals.
- Acquaintance with guiding proposals and managing others.

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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