Associate Director Statistical Programming - Biotech

Proclinical are recruiting for an Associate Director Statistical Programming - Biotech to join a biotech organisation. This role is on a permanent basis and is located in Frankfurt.

Responsibilities:

• Assist with the development and execution of an international programming ecosystem to facilitate successful project deliverables.
• Write and evaluate programming specifications and validation.
• You will develop divisional programming standards to meet business requirements and regulatory needs, facilitating effective and seamless production of deliverables.
• The ideal candidate will set up tools for effective verification of derived datasets, such as SDTM and ADaM, and TLFs.
• Form novel solutions to standardise, automate and optimise effectiveness and quality to meet business requirements and meet regulatory needs.
• Contribute to the development and execution of the company's centralised data warehouse.
• Other duties may be assigned to this role.

Key Skills and Requirements:

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

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com

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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