Description

Manage integrated summary of safety (ISS) datasets and outputs for multiple clinical studies.

This role is remote.

Responsibilities

• Oversee CRO production of ISS datasets and outputs for up to 18 studies.
• Review integrated ADaM datasets and TLF outputs for accuracy and compliance.
• Collaborate with study statisticians to ensure project alignment and technical consistency.
• 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 specification design.
• Experience with specification review and dataset quality control.
• Proficiency in Table, Listing, and Figure (TLF) production and QC.
• Hands-on experience with Define.XML standards.
• Bachelor’s Degree in a relevant field.

Key Skills

Education

Bachelor’s Degree