Statistical Programmer II

Job not on LinkedIn

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🖥 Software Engineer

🦅 H1B Visa Sponsor

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Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

💼 Consulting

📦 Logistics

Manufacturing • Consulting • Logistics

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Provide statistical programming support to clinical trials • Produce statistical analyses, including generating and validating SDTM datasets, analysis datasets, tables, listings, and figures • Perform assigned statistical programming for clinical trial analysis and reporting • Work under the direction of senior statistical programmers • Review Statistical Analysis Plans before programming analyses • Apply appropriate statistical methods for data analysis • Assist in designing and developing SAS macros and other utilities • Generate tables, listings, and figures according to protocols, Statistical Analysis Plans, and approved client requests • Participate in statistical program validation and quality control activities • Assist with SDTM aCRF and specifications and complete programming and validation of CDISC SDTM and ADaM datasets • Develop define.xml and tables of contents for regulatory submissions • Collaborate with Clinical Operations, Project Management, and Data Management to support successful project execution and client satisfaction • Program data-cleaning checks • Complete assigned tasks within budgeted hours • Use project infrastructure for SAS datasets and SAS code • Follow Ora standard procedures, sponsor requirements, quality systems, data-integrity processes, business ethics, and regulatory requirements

🎯 Requirements

• Bachelor's degree in computer science, statistics, or another related scientific field and two (2) to four (4) years of relevant professional experience; or an equivalent combination of relevant education and/or experience • Sound analytical skills and ability to process scientific and medical data • Proficient SAS programming skills required • Expert knowledge in SAS/Base • Working knowledge in SAS/Stat and SAS Macros • Basic understanding of SAS/Graph • Experience manipulating and analyzing SAS data • Ability to independently identify data issues, clearly present problems, and implement effective, time-efficient solutions • Familiarity with clinical trial design and analysis activities • Basic knowledge of FDA/CFR and ICH/GCP regulatory guidelines • BASE SAS and Advanced SAS Certification or equivalent experience preferred • Ability to set goals, create structure, and deliver timely, high-quality work • Ability to communicate and collaborate effectively • Full-time employees must work a minimum of 30 hours per week for benefit eligibility

🏖️ Benefits

• Comprehensive medical, dental, and vision healthcare options beginning day 1 • Flexible PTO and unlimited sick time • 14 company-paid holidays • 401(k) plan through Fidelity with company match • Adoption and fertility assistance • 16 weeks paid parental leave • Company-paid life and disability insurance • Remote workspace and wellness reimbursement • Employee Assistance Program • Career development opportunities • Opportunities to work with colleagues across the globe • Opportunity to research new ophthalmic therapies with global patient impact