• , US

Company:  Confidential

Job Title: Statistical Programming Dir.

Job Number: 74045

Location: , US

Job Description

Join our expanding clinical team as the first Associate Director/Director, Statistical Programming. Reporting to the Head of Development Operations, you’ll oversee all statistical programming deliverables, ensuring compliance with company SOPs and ICH/GCP guidance, and collaborate closely with the Director of Biostatistics to put in place programming policies and procedures.

Responsibilities

* Oversee statistical programming for various tasks. * Collaborate with biostatisticians and IT teams to maintain secure computing infrastructure. * Manage personnel and contractors for quality deliverables within budget. * Review study documents. * Ensure compliance with industry standards for data specifications. * Author or review SOPs as necessary. * Perform ad hoc analysis and data review. * Establish project timelines and conduct statistical analyses efficiently. * Develop and manage resources for data processing. * Fulfill additional responsibilities as needed.

Required Skills

* Bachelor’s/Master’s in relevant field with 10+ years of statistical programming experience * Proficient in industry standards for clinical study data and regulatory reporting * Advanced SAS programming skills. * Experience in oncology is a plus. * Extensive leadership in early-phase clinical studies. * Demonstrated ability to manage outsourced programming tasks. * Expertise in electronic submission requirements and technology. * Strong analytical and communication skills.

Application Deadline: 2024-03-18

 

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