Principal Statistical Programmer

Puma Biotechnology, Inc.; Los Angeles (CA); Remote; USD 175,000 - 210,000; Full time

Job summary

Puma Biotechnology, Inc. is seeking a Principal Statistical Programmer to collaborate with biostatistics teams, CRAs, data managers and regulatory staff to meet study deliverables and timelines for data analysis and reporting. This is a remote position with a home-office setup.

The role requires 12+ years of clinical trial programming experience, a CS/Math/Statistics degree, CDISC (SDTM/ADaM) expertise in Oncology, and advanced SAS macro skills; proficiency in Python, R, and JavaScript is a plus.

Qualifications

• Bachelor degree in CS/Math/Statistics or related quantitative field.
• Minimum of 12 years of clinical trial programming experience.
• Strong knowledge of CDISC (SDTM/ADaM) in Oncology.
• Experience with regulatory submissions and data standards.

Responsibilities

• Generate or oversee statistical output for study reports.
• Ensure programming and documentation meet procedures.
• Lead development of SAS macros for standard outputs and CDISC.
• Contribute to SAS Programming Work Instructions and Standards.
• Produce listings for data checking and data quality.
• Develop techniques using Python, R, or JS to enhance analysis.
• Provide ad-hoc data outputs for regulatory needs.
• Attend study team meetings as primary statistical programming contact.

Skills

Organizational skills

Prioritization

Communication skills

CDISC (SDTM/ADaM)

Education

Bachelor's degree in Computer Science, Mathematics, Statistics or related quantitative field

Tools

SAS

Python

R

JavaScript

Job description

Description

The Principal Statistical Programmer works collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.

Major Duties/Responsibilities

• 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.

Competencies

• 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.)

Required Education and Professional Experience

• 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

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.

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. Up to 20% travel

Compensation Range

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.

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.