Principal Statistical Programmer

• Generates or oversees the production of statistical output (e.g., tables, listings) for study reports and integrated summaries either in-house or vendor supplied
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
• Leads development of robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation
• Provides input in the creation and revision of SAS Programming Work Instructions and Standards
• Oversees or generates the production of clinical listings for data checking, data quality and review.
• Develops techniques with other software (Python, R, JS, etc.) that enhances data analysis, visualization, or the production of statistical output.
• Produce ad-hoc data or statistical output for commercial, partner, or regulatory needs as required.

Operating Procedures

• May attend study team meetings as the primary statistical programming contact.

• Excellent organizational skills and ability to prioritize tasks
• Must be able to work under tight timelines
• Possess excellent communication and interpersonal skills
• Fluency in CDISC (SDTM, ADaM) particularly in Oncology and the associated domains (TU, TR, RS, ADTTE, etc.), * Bachelor’s degree in a Computer Science, Mathematics, Statistics or a quantitative/ analytical field
• Minimum of 12 years of clinical trial programming experience in the biotechnology/pharmaceutical contract research industry
• Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
• Basic knowledge of coding dictionaries- MedDRA and WHODRUG, This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds. Up to 20% travel

This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working outside of these hours and may extend to evenings and weekends as business needs require., The salary range for this role is $175,000 - $210,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.