Senior Statistical Programmer
LanceSoft
Job Description Title: Senior Statistical Programmer
Dura tion: Jun 8 Dec 31, 2026
Location: Irvine, CA, 92618
Schedule: 1st Shift, 9: 00 AM - 5: 00 PM
TECHNICAL SKILLS
Must Have
Nice To Have
JOB DESCRIPTION
Key Responsibilities
Primary Responsibilities
Required Qualifications
Education & Experience
Required Technical Skills
Required Professional Skills
Nice to Have Skills
Additional Information
Dura tion: 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.
Vacancy posted 2 days ago
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