Statistical Programmer II

Job not on LinkedIn

🕒 May 15

🇺🇸 United States – Remote

💵 $107.2k - $138.7k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🖥 Software Engineer

🚫👨‍🎓 No degree required

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting • Assesses the quality and consistency of analysis data and performs cross-study analyses • Uses internal macros or writes SAS® macros to automate study deliverables • Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies • Has sufficient understanding to follow an analysis plan and provide programming support for study deliverables • Assists in the review of GSI Policies, SOPs and other controlled documents • Provides input to and participates in Programming and Clinical Data Science meetings • Contributes to the continuous improvement of Programming Environment • Demonstrates SAS programming proficiency • Generates the production of statistical analysis datasets and outputs (e.g., tables, figures, and listings) for study reports and integrated summaries • Has knowledge of clinical trial study design and electronic data submission requirements • Assists with study and systems audits, and responds to audit questions and findings • Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies and helps define the data set

🎯 Requirements

• Master’s and 2 years of relevant experience OR Bachelor’s and 4 years of relevant experience • Degree in Biostatistics/Computer Science or equivalent (preferred) • 5+ years of pharmaceutical/CRO experience (preferred) • Prior experience in oncology, hematology, cell therapy strongly preferred • Knowledge of long term follow up trial knowledge strongly preferred • Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.) (preferred) • In-depth understanding of clinical programming and/or statistical programming processes and standards • In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH) • Extensive experience with statistical programming using the SAS and R software including development and use of SAS Macros, R Packages • Experience with development of CDISC standardized ADaM datasets and specifications • Advanced knowledge in SDTM domains • Proven experience in leading programming activities • Excellent interpersonal, communication, problem solving, and analytical skills. • Willing to handle multiple projects and ad-hoc tasks

🏖️ Benefits

• company-sponsored medical, dental, vision, and life insurance plans • discretionary annual bonus • discretionary stock-based long-term incentives (eligibility may vary based on role) • paid time off