Statistics & Statistics Programming Spec 3

Soho Square Solutions; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Soho Square Solutions in Irvine, CA is seeking a Statistics & Statistics Programming Specialist 3 for a 6-month contract on site. The Senior Statistical Programmer – Contractor will develop and validate analysis datasets and outputs for clinical studies, collaborating with Biostatistics and Clinical Data Management.

You will create, modify, and validate SAS programs to produce tables, listings, and figures, ensuring inspection-ready documentation.

Qualifications

• 8+ years of relevant statistical programming experience or 6+ years with a master’s degree
• Experience with SAS programming for clinical trials and CDISC standards (SDTM/ADaM)
• Experience developing tables, listings, and figures; regulatory submissions experience

Responsibilities

• Develop complex analysis datasets, specifications, and summary outputs (tables, listings, figures) for 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 with inspection-ready documentation
• Support ad hoc analyses in collaboration with the designated statistician and data management team
• Review CRFs and database specifications with the study team; identify risks and communicate them clearly

Skills

SAS programming

SAS Base

SAS/STAT

SAS Macros

CDISC SDTM/ADaM

Regulatory knowledge (GCP/ICH/FDA/ISO)

R or Python

Cross-functional collaboration

Data management collaboration

Education

Bachelor’s degree in Statistics/Math/CS

Master’s degree in a related field

Tools

SAS software

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Job Title: Statistics & Statistics Programming Spec 3

Client: Major Medical Device client

Duration: 06 Months Contract

Note:

SPEC 3 Statistical Programmer, Irvine, CA (on-site)

6-month contract with strong temp-to-perm intent

Work Schedule and Interview Process

Schedule: Mon–Thu on-site, Fri WFH (not technically hybrid)

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.

This position is based in Irvine, California, with an expectation of onsite presence approximately 3-4 days per week.

Key Responsibilities

Primary Responsibilities

Develop complex analysis datasets, specifications, and summary outputs (tables, listings, figures) 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 8+ years of relevant statistical programming experience

OR

Master’s degree (or equivalent) in a related field with 6+ 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:

• 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.

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.