Associate Director, Statistical Programming

🕒 June 9

🇺🇸 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%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

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

• Collaborate with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting • Generate or oversee programming deliverables, including tables and listings, for study reports and integrated summaries • Anticipate resource needs • Ensure programming and related documentation comply 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 • Anticipate and resolve study-related issues and conflicts within therapeutic projects • Serve as a key resource on multiple, time-sensitive, and complex tasks • Build buy-in and support and negotiate timelines • Manage critical deadlines and ensure tasks are completed within designated timeframes • Identify and lead 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 and 3+ years’ experience in pharma/biotech • Extensive pharmaceutical/CRO experience • 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 regulatory submission activities • In-depth understanding of clinical and statistical programming processes and standards • In-depth understanding of regulatory requirements relevant to statistical programming, including GCP and ICH • Extensive experience with SAS software, including development and use of SAS Macros • Advanced knowledge of CDISC standards: 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, reporting processes, and regulatory reporting requirements for FDA, PMDA, and other global agencies • Extensive hands-on experience with regulatory submissions, including integrated analysis, FDA and PMDA filings, RtQs, AdCom preparation, and inspections

🏖️ 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 • Reasonable accommodation support during the application process