Associate Director, Statistical Programming

🔥 11 hours ago

🇺🇸 United States – Remote

💵 $177.9k - $230.2k / year

⏰ Full Time

🔴 Lead

👔 Director

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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. • Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries. • Anticipates resource needs. • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures. • Directs the design and/or coding of analysis files. • Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. • Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines. • Identifies and leads strategic initiatives for the programming group.

🎯 Requirements

• BS degree in Biostatistics/Computer Science or equivalent and 10+ years’ experience in pharma/biotech -OR - MS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech –OR - PhD degree in Biostatistics/Computer Sciences or equivalent 3+ years of experience in pharma/biotech • Excellent verbal and written communication skills • Extensive hands-on experience with regulatory submissions including integrated analysis and post-submission activities such as FDA and PMDA filing, RtQs, AdCom preparation, and inspections • In-depth understanding of clinical programming and/or statistical programming processes and standards • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)

🏖️ Benefits

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