Senior Statistical Programmer (Contract) (Biotech)

TL;DR

Senior Statistical Programmer (Biotech): Contributing expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for hirify.global development programs with an accent on strong technical proficiency and collaboration across teams. Focus on programming outputs as stated in the analysis plan, reviewing Statistical Analysis Plan, and ensuring programs are appropriate for regulatory submission.

Location: Hybrid in our NYC Office or remote in the East Coast.

Company

hirify.global plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health.

What you will do

• Leading and coordinating the programming activities within agreed timelines.
• Managing the reporting of studies internally and externally.
• Programming outputs as stated in the analysis plan.
• Working closely with study team members, mainly with the study statistician.
• Create and review SDTM and ADaM study specifications.
• Ensure programs, datasets, outputs are appropriate for regulatory submission.

Requirements

• Extensive years experience in statistical programming.
• CDISC expertise.
• Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R.
• Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting.
• Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions.
• Must have employment rights in the country to which you are applying.

Culture & Benefits

• Committed to building a workplace where everyone’s wellbeing matters.
• We are proud of our commitment to diversity and equality.