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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Puma Biotechnology Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, status as a protected veteran, or any other characteristic protected by law.
