Associate Director, Statistical Programming

🕒 June 8

🇺🇸 United States – Remote

💵 $177.9k - $230.2k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 45%

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $3.5M Post-IPO Debt - Gilead Sciences on 2024-11

Healthcare • Biotechnology • Pharmaceuticals

Gilead Sciences is a global biopharmaceutical company focused on researching, developing, and commercializing medicines primarily in virology, oncology, and inflammation. The company advances transformative therapies, runs extensive clinical programs and research collaborations, and supports access, global health, and community funding initiatives. Gilead also emphasizes corporate responsibility, sustainability, and inclusion while maintaining a broad pipeline of therapies and patient access programs.

📋 Description

• Collaborate with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting • Generate or oversee programming deliverables, such as tables and listings, for study reports and integrated summaries • Anticipate resource needs • Ensure programming and corresponding documentation are completed consistently with departmental procedures • Direct the design and/or coding of analysis files • Provide primary and secondary programming support as needed • Harmonize strategic initiatives, such as process improvement, across a therapeutic area or equivalent • Interact with other departments to define and produce user-defined statistical reports and ad hoc requests • Identify and lead strategic initiatives for the programming group • Manage critical deadlines and ensure tasks are completed within designated timeframes • Resolve study-related issues and conflicts within therapeutic projects

🎯 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 and 3+ years’ experience in pharma/biotech • Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred • Submission knowledge is strongly preferred • Extensive hands-on experience in pivotal studies, integrated analysis, and other regulatory submission related activities • In-depth understanding of clinical programming and/or statistical programming processes and standards • In-depth understanding of regulatory requirements relevant to statistical programming, including GCP and ICH • Extensive experience with statistical programming using SAS software, including development and use of SAS Macros • Advanced knowledge in CDISC standards, including CDASH, SDTM, and ADaM • Proven experience in complex and fast turnaround programming activities • Excellent verbal and written communication, interpersonal, problem solving, and analytical skills • Thorough understanding of clinical trial design and reporting processes and regulatory reporting requirements, including electronic data submissions for multiple therapeutic areas with FDA, PMDA, and other global agencies • 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 • Proven ability to anticipate and resolve study-related issues and conflicts • Proven track record as a key resource on multiple, time-sensitive, and complex tasks • Proven ability to create buy-in, negotiate timelines, manage critical deadlines, and resolve issues

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance