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Associate Director Statistical Programming Infectious Diseases

Frankfurt

Veröffentlicht am 11.07.2024 Festanstellung

Proclinical is actively seeking an expert in Statistical Programming with a focus on Infectious Diseases. This role involves putting global statistical programming strategies into action and contributing to the creation and expansion of a global programming ecosystem.

Responsibilities:

Collaborate with the Director of Statistical Programming to implement global strategies related to technological innovation, automation and processes.

Assist with the development and application of a global programming ecosystem to ensure successful project deliverables.

Work collaboratively with the Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting.

Independently perform or oversee the production and/or validation of programming deliverables for study reports and integrated summaries.

Anticipate resource needs and work with management to ensure adequate long-term resource allocation within a therapeutic project.

Ensure quality control on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements.

Participate in the development of a global programming standard library to enable consistent and efficient project deliverables across portfolios.

Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications and provide programming support to regulatory submissions.

Key Skills and Requirements:

Bachelor's degree in Statistics, Mathematics, Computer Science or another related discipline, an advanced degree is preferred.

Proficiency in programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.

Solid understanding of FDA, EMA, ICH, and global regulations and guidelines.

Knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards.

Strong interpersonal skills and exceptional English written and oral communication skills.

Project management experience and strong analytical and problem-solving skills.

Ability to work in a fast-paced, dynamic team environment.

Standort

Proclinical, Frankfurt

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