Principal Statistical Programmer

🔥 1 hour ago

🏄 California – Remote

🏄 California – Remote

💵 $175k - $210k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 0%

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Puma Biotechnology, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

🔥 Funding within the last year

💰 POST IPO EQUITY on 2025-12

Biotechnology • Pharmaceuticals • Healthcare

Puma Biotechnology, Inc. is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel therapeutics for the treatment of cancer. The company markets an FDA‑approved treatment and is actively running clinical trials of alisertib (branded ALISCA®) for small cell lung cancer (ALISCA®-Lung1 and -Lung2) and metastatic breast cancer (ALISCA®-Breast1). Puma provides clinical data sharing, extended access programs, and maintains investor, corporate governance, and regulatory information publicly.

📋 Description

• Collaborate with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers, and other Clinical, Global Drug Safety, Regulatory, and Project Management staff • Generate or oversee statistical outputs, including tables and listings, for study reports and integrated summaries • Ensure programming and documentation comply with departmental procedures • Lead development of robust, flexible SAS macro programs or modules for standard outputs and CDISC implementation • Provide input into SAS Programming Work Instructions and Standards • Oversee or generate clinical listings for data checking, data quality, and review • Develop techniques using Python, R, JavaScript, and other software to enhance data analysis, visualization, or statistical output production • Produce ad-hoc data or statistical output for commercial, partner, or regulatory needs • Attend study team meetings as the primary statistical programming contact when required • Work Monday through Friday, approximately 8:30 AM to 5 PM, with occasional work outside these hours • Work remotely from a home office

🎯 Requirements

• Bachelor's degree in 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 trial design and reporting processes • Understanding of regulatory reporting requirements, including electronic data submissions and CDISC implementation • Fluency in CDISC (SDTM, ADaM), particularly in Oncology and associated domains (TU, TR, RS, ADTTE, etc.) • Basic knowledge of coding dictionaries: MedDRA and WHODRUG • Excellent organizational skills and ability to prioritize tasks • Ability to work under tight timelines • Excellent communication and interpersonal skills • Ability to occasionally work evenings and weekends as business needs require • Ability to occasionally lift or move up to 25 pounds

🏖️ Benefits

• Annual bonus target • Robust benefits package • Remote work from a home office • Up to 20% travel

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