Description

You will manage integrated summary of safety (ISS) datasets and outputs for 18 studies.

Responsibilities

• Oversee CRO production of ISS datasets and outputs.
• Review integrated ADaM datasets and TLF outputs.
• Collaborate with study statisticians to ensure project alignment.
• Lead team meetings and propose solutions to integration difficulties.
• Identify potential process flow risks and implement preventative measures.

Required Skills

• 5+ years of experience in statistical programming.
• Expertise in ADaM dataset production and spec design.
• Experience with spec review and dataset QC.
• Proficiency in TLF production and QC.
• Hands-on experience with Define.XML.
• Strong background in spec design and review processes.
• Bachelor’s Degree.

Key Skills

Education

Bachelor’s Degree