Principal Statistical Programmer

bdx; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BD, a leading global medical technology company, seeks a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies. You will develop analysis datasets, specifications, tables, listings, and figures, and create, modify, and maintain SAS programs meeting regulatory standards.

You will validate outputs, ensure traceability, support planned analyses with statisticians, review CRFs and data derivations with CDM and Biostatistics, and communicate risks

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field; 5+ years of statistical programming experience OR
• Master’s degree in related STEM field with 3+ years of experience; clinical trials programming experience preferred.
• Experience with SAS programming for clinical trial data and regulatory submissions.

Responsibilities

• Develop analysis datasets, specifications, and outputs (tables/listings/figures) for clinical study reports and regulatory submissions.
• Create/modify SAS programs meeting regulatory standards for data management and reporting.
• Perform independent program validation and maintain compliant documentation.
• Support planned analyses and respond to data review questions with statisticians.
• Collaborate with Clinical Data Management and Biostatistics on CRFs, database specs, and data derivations.
• Identify programming risks and data issues and communicate them to the study team.

Skills

SAS programming

SAS Base

SAS/STAT

SAS Macros

CDISC SDTM

CDISC ADaM

Regulatory knowledge

GCP/ICH/FDA

R or Python

Data reporting

Education

Bachelor's in Statistics/related STEM

Master's in related STEM

Tools

SAS Base

SAS/STAT

SAS Macros

Excel

PowerPoint

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Role Purpose

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 Principal Statistical Programmer 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.

Required Skills/Experience

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field or other STEM Field with 5+ years of relevant statistical programming experience
  OR




• Master’s degree (or equivalent) in a related STEM field with 3+ years of relevant statistical programming experience




• Demonstrated experience performing statistical programming in a clinical trials environment (pharmaceutical and/or medical device).

• 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).

• 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.

Preferred Skills/Experience

• Prior participation in regulatory submissions or submissions‑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 position and does not include formal people‑management responsibilities.