Job Description
Title: Senior Statistical Programmer
Duration: Jun 8 Dec 31, 2026
Location: Irvine, CA, 92618
Schedule: 1st Shift, 9: 00 AM - 5: 00 PM
TECHNICAL SKILLS
Must Have
- Base SAS
- Clinical Data Interchange Standards Consortium (CDISC) Standards
- Data Manipulation
- SAS Macros
- SAS/STAT
Nice To Have
- Python
- R
JOB DESCRIPTION
- Provide hands on statistical programming support for clinical studies, including development and validation of analysis datasets and statistical outputs, in accordance with regulatory and company standards.
- The Senior Statistical Programmer Contractor is expected to work independently, deliver high quality programming deliverables, and collaborate effectively with Biostatistics and Clinical Data Management.
Key Responsibilities
Primary Responsibilities
- Develop complex analysis datasets, specifications, and summary outputs (tables, listings, figures, and graphs) for inclusion in clinical study reports, regulatory submissions, and internal presentations.
- Create, modify, and maintain SAS programs that meet regulatory and company standards to ensure efficient programming, reporting, review, and traceability.
- Perform independent program review and validation, ensuring complete, accurate, and inspection ready documentation in compliance with applicable regulations and internal procedures.
- Support ad hoc and planned analyses in collaboration with the designated statistician, including responses to data review questions.
- Partner with Clinical Data Management and Biostatistics to review CRFs, database specifications, edit checks, and data derivations as needed.
- Proactively identify programming risks, data issues, or efficiency opportunities and communicate them clearly to study team members.
- Works independently with minimal supervision, receiving high level objectives and delivering agreed upon outputs.
- Evaluates alternative programming approaches and applies sound judgment in accordance with regulatory and quality standards.
- May provide technical guidance or support to other programmers, as appropriate.
- Responsible for managing assigned programming tasks and timelines within the scope of the contract.
Required Qualifications
Education & Experience
- Bachelor s degree in Statistics, Mathematics, Computer Science, or a related field with 5+ years of relevant statistical programming experience
OR - Master s degree (or equivalent) in a related field with 3+ years of relevant statistical programming experience
- Demonstrated experience performing statistical programming in a clinical trials environment (pharmaceutical and/or medical device).
Required Technical Skills
- Strong hands on experience with SAS programming for clinical trial data including SAS Base, SAS/STAT, and SAS Macros.
- Proven experience developing and validating:
- Analysis datasets
- Tables, listings, and figures
- Solid understanding of regulatory requirements and guidelines applicable to clinical research (e.G., GCP, ICH, FDA, ISO).
- Experience with CDISC standards (e.G., SDTM, ADaM).
- Experience supporting programming deliverables that are inspection ready.
- Proficiency interfacing SAS outputs with common productivity tools (e.G., Microsoft Excel, Word, PowerPoint).
Required Professional Skills
- Strong analytical, problem solving, and organizational skills.
- High attention to detail and commitment to data quality.
- Clear written and verbal communication skills.
- Ability to collaborate effectively with cross functional stakeholders, including statisticians and data managers.
- Ability to manage competing priorities in a fast paced project environment.
Nice to Have Skills
- Prior participation in regulatory submissions or submission related deliverables.
- Experience reviewing or validating programming deliverables from CROs or vendors.
- Development of SAS macros or tools that improve programming efficiency.
- Ability to program in other statistical languages such as R or Python.
Additional Information
- This role is an individual contributor contract position and does not include formal people management responsibilities.
- The contractor is expected to adhere to all applicable quality, compliance, and safety requirements relevant to their work.
Numbers & Facts
| Location | Irvine, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $75 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Biostatisticsunmatched
- Biotech and Pharmaceuticalunmatched
- Case Report Form (CRF)unmatched
- Clinical Dataunmatched
- Clinical Data Interchange Standards Consortium (CDISC)unmatched
- Clinical Data Managementunmatched
- Clinical Researchunmatched
- Clinical Supportunmatched
- Clinical Trialunmatched
- Code Reviewsunmatched
- Communication Skillsunmatched
- Computer Programmingunmatched
- Computer Scienceunmatched
- Contract Research Organization (CRO)unmatched
- Cross-Functionalunmatched
- Data Managementunmatched
- Data Qualityunmatched
- Data Setsunmatched
- Detail Orientedunmatched
- Documentationunmatched
- FDA (Food and Drug Administration)unmatched
- GCP (Good Clinical Practices)unmatched
- ICH Regulationsunmatched
- ISO (International Organization for Standardization)unmatched
- Mathematicsunmatched
- Medical Equipmentunmatched
- Microsoft Excelunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Organizational Skillsunmatched
- People Managementunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Program Evaluationunmatched
- Project/Program Managementunmatched
- Python Programming/Scripting Languageunmatched
- Quality Metricsunmatched
- R Programming Languageunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Reportsunmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Risk Analysisunmatched
- Safety Trainingunmatched
- Statistical Analysis System (SAS)unmatched
- Statistical Programming Languagesunmatched
- Statisticsunmatched
- Team Playerunmatched
- Technical Leadershipunmatched
- Technical Supportunmatched
- Traceabilityunmatched
- Writing Skillsunmatched
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