Job Description
The Programming and Statistics Manager will manage statistical programming activities across multiple studies and programs from study start-up through study closure. This role ensures completion per established project team goals and objectives. They will collaborate closely with a cross-functional team, and contract research organizations in a fast-paced, high growth environment, guaranteeing that clinical data and statistical analysis are complete, high quality, and delivered on time and within budget. Responsibilities include managing all statistical activities from CRF design through clinical study report for in-house and outsourced clinical trials with minimal supervision.
Qualifications
• Minimum of 5 years of experience working within a pharmaceutical or CRO environment, with experience in Phase I, II and III studies, from start-up through closure.
• MUST HAVE strong vendor management experience.
• Demonstrated proficiency in SAS.
• Demonstrated proficiency in development of SDTM, ADaM packages and development of analysis output
• Thorough knowledge of applicable regulatory rules and guidelines.
• Excellent organizational skills and attention to detail.
• Effective written and verbal communication and interpersonal skills.
• Able to set priorities and juggle multiple projects and demands.
• Able to think critically and independently and be a proactive problem-solver.
• Able to work independently while exercising initiative, flexibility, and sound judgment.
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 5%
Location: United States
Posted: Aug. 20, 2024, 8:24 a.m.
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