Associate Director Statistical Programming

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.
• The ideal candidate will develop divisional programming standards to meet business requirements and regulatory needs, facilitating effective and seamless production of deliverables.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at 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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