Principal Statistical Programmer

This is a fully remote position, open to applicants in California.

📋 Description

• Collaborate with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers, and other Clinical, Global Drug Safety, Regulatory, and Project Management personnel.

• Generate or supervise statistical outputs, including tables and listings, for study reports and integrated summaries.

• Ensure that programming and documentation adhere to departmental protocols.

• Lead the creation of resilient and adaptable SAS macro programs or modules for standard outputs and CDISC implementation.

• Contribute to SAS Programming Work Instructions and Standards.

• Oversee or create clinical listings for data verification, quality checks, and reviews.

• Develop methodologies using Python, R, JavaScript, and other software to improve data analysis, visualization, or the generation of statistical outputs.

• Produce ad-hoc data or statistical outputs to meet commercial, partner, or regulatory requirements.

• Participate in study team meetings as the primary contact for statistical programming when necessary.

• Work Monday through Friday, approximately from 8:30 AM to 5 PM, with the possibility of occasional work outside these hours.

• Operate remotely from a home office.

⛳️ Requirements

• Bachelor's degree in Computer Science, Mathematics, Statistics, or a quantitative/analytical discipline.

• At least 12 years of experience in clinical trial programming within the biotechnology/pharmaceutical contract research sector.

• Comprehensive understanding of clinical trial design and reporting methodologies.

• Familiarity with regulatory reporting requirements, including electronic data submissions and CDISC implementation.

• Proficiency in CDISC (SDTM, ADaM), especially in Oncology and related domains (TU, TR, RS, ADTTE, etc.).

• Basic understanding of coding dictionaries: MedDRA and WHODRUG.

• Strong organizational skills with the ability to prioritize tasks effectively.

• Capability to work under tight deadlines.

• Excellent communication and interpersonal abilities.

• Willingness to occasionally work evenings and weekends as business needs dictate.

• Ability to occasionally lift or move items weighing up to 25 pounds.

🏝️ Benefits

• Annual bonus target.

• Comprehensive benefits package.

• Remote work opportunity from a home office.

• Up to 20% travel.