Statistical Programmer II
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Job Description
Statistical Programmer II supporting statistical analyses and SAS programming for Ora’s ophthalmic clinical-trial research. Developing and validating CDISC datasets, tables, listings, and figures.
Responsibilities:
- 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
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