Principal Statistical Programmer

Responsibilities

• Lead and support all programming activities for clinical studies, regulatory submissions, and ad hoc/post hoc analyses.
• Manage programming activities related to data management, statistical analysis, and reporting to ensure timely delivery.
• Develop and manage specifications for SDTM and ADaM datasets and prepare data submission packages.
• Create global standard macros to enhance the efficiency of the Statistical Programming Group.
• Oversee programming activities to ensure adherence to protocols, statistical analysis plans, and GCP regulations.
• Mentor less experienced programmers and contribute to the continuous improvement of statistical programming processes.
• Collaborate with biostatistics, data management, clinical research, and regulatory affairs teams.

Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• 8+ years of statistical programming experience with a Bachelor's degree, or 6+ years of relevant experience with a Master's degree.
• Proven experience in the Biotech, Pharmaceutical, or health-related industry.
• Proficiency in SAS Base, STAT, Graph, and Macro.
• Extensive experience with CDISC data standards, specifically SDTM and ADaM.
• Strong problem-solving, debugging, and interpersonal communication skills.

Preferred Qualifications

• Master's degree in a relevant quantitative or life sciences field.
• Experience with electronic submissions in the eCTD format.
• Experience supporting Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE).

Benefits

• Competitive benefit package.
• Paid company holidays, vacation, and volunteer time.
• Summer Fridays and other unique time-off perks.
• Learning and development opportunities.
• Access to Employee Resource Groups.

About the Company

Kenvue is the house of iconic brands including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S®, and BAND-AID®. Built on over a century of heritage and rooted in science, we are dedicated to delivering the extraordinary power of everyday care to millions of people worldwide.