Senior Statistical Programmer

Lancesoft

Irvine, CA

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JOB DETAILS

SALARY

$75

SKILLS

Analysis Skills, Biostatistics, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Research, Clinical Support, Clinical Trial, Code Reviews, Communication Skills, Computer Programming, Computer Science, Contract Research Organization (CRO), Cross-Functional, Data Management, Data Quality, Data Sets, Detail Oriented, Documentation, FDA (Food and Drug Administration), GCP (Good Clinical Practices), ICH Regulations, ISO (International Organization for Standardization), Mathematics, Medical Equipment, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Organizational Skills, People Management, Presentation/Verbal Skills, Problem Solving Skills, Program Evaluation, Project/Program Management, Python Programming/Scripting Language, Quality Metrics, R Programming Language, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Safety Training, Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Team Player, Technical Leadership, Technical Support, Traceability, Writing Skills

LOCATION

Irvine, CA

POSTED

2 days ago

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.

Scope & Level of Independence

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.

About the Company

Lancesoft

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.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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