Support Safety Analytics with ADaM /TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables
Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display
Provide ADaM /TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs
Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Must be located in North America with no sponsorship needs
Project Statisticians who are experienced with clinical development, MS or PhD in Statistics/Biostatistics
3+ years of experience
Strong programming skills (R/SAS)
Strong experience reviewing ADaM datasets and TFLs (standard and customized output review)
Ability to follow data specifications and programming specifications and provide clear, actionable review comments
Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors
Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward
R/SAS programming skills

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time

Senior Safety Biostatistician – North America

Key skills