Statistical Engineering Jobs in Irvine, CA (NOW HIRING)

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.

Role Purpose

Provide handson 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 highquality 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 inspectionready 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 highlevel objectives and delivering agreedupon 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 handson 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 inspectionready.

• Proficiency interfacing SAS outputs with common productivity tools (e.g., Microsoft Excel, Word, PowerPoint).

• Strong analytical, problemsolving, and organizational skills.

• High attention to detail and commitment to data quality.

• Clear written and verbal communication skills.

• Ability to collaborate effectively with crossfunctional stakeholders, including statisticians and data managers.

• Ability to manage competing priorities in a fastpaced project environment.

Preferred Skills/Experience

• Prior participation in regulatory submissions or submissionsrelated 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 peoplemanagement responsibilities.

• The programmer is expected to adhere to all applicable quality, compliance, and safety requirements relevant to their work.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information