The primary objective of this position is to provide strategic and technical leadership for the Statistical Programming function, ensuring the timely delivery of high-quality programming deliverables in support of clinical development and regulatory submissions. This role establishes departmental standards, oversees the production of datasets, tables, listings, and figures (TLFs), ensures compliance with regulatory and industry standards, and partners cross-functionally to support development programs. This is a technical leadership position that will also include the management and development of statistical programmers.

Major Duties / Responsibilities

• Represent programming at study and project team meetings and collaborate with other functions within clinical development for all activities related to analyses of clinical trial data
• Create datasets, files, tables, listings, and figures (TLFs), as needed for internal milestones, regulatory requests, commercial inquiries, ad-hoc requests, and marketing applications
• Apply and promote consistent programming standards through standard processes and SOPs
• Maintain appropriate documentation surrounding clinical data and/or programs
• Evaluate processes to implement for improvement in standards development and other tools that benefit the department
• Manage the implementation of dataset and TLF processes and methods
• Programming support for activities for functions outside of clinical development
• Partner with the biometrics head to manage the budget and resource planning for statistical programming area
• Coordinate workloads within programming to meet company goals

Supervisory Duties

• Will oversee & manage other programmers
• Conduct annual reviews, performance evaluations, and goal setting for direct reports

Required Education and Professional Experience

• BS in Mathematics, Computer Science, Statistics, or related field
• At least 8 years of progressive statistical programming experience
• Prior management experience leading a team of statistical programmers
• Expert knowledge of all aspects of CDISC, including SDTM, ADaM, metadata, biomedical concepts, and controlled terminology
• Regulatory and industry requirements
• Proficiency of EDC
• Expert in SAS (Base, STAT, GTL, Macro)
• Windows or UNIX operating system on a remote server

Preferred Education and Experience

• MS in Mathematics, Statistics, or Biostatistics
• FDA, EU, PMDA and NMPA submissions
• 10-12 years of progressive statistical programming experience
• 5+ years of management experience leading a team of statistical programmers
• Python, R, Shiny, Plotly, ChartJS

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Position Type/Expected Hours of Work

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.

Work Environment

This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.

Travel

The role requires infrequent travel. Minimal travel may be required for meetings and/or conferences, up to 5%.

Physical Demands

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.

Compensation Range

The salary range for this role is $220,000 - $250,000 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.

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