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Statistics & Statistics Programming Specialist 3 SAS Programmer

Irvine, CA
Permanent
Sunrise Systems Inc

Posted

Our client, a leading Medical Device Manufacturing Company is looking for Statistics & Statistics Programming - Specialist - 3 / SAS Programmer and This is for an initial duration of 06 Months Contract Remote Role

Job Title: Statistics & Statistics Programming - Specialist - 3 / SAS Programmer
Job Id: (phone number removed)
Location: Remote Role
Duration: 06 Months Contract
Position Type: Hourly Contract Position (W2 only)

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.
Compensation: The hourly rate for this position is between $75.00-$78.00 per hour.

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].

Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Qualified candidates please send your word format updated resume at the earliest toPavan: (url removed) [(phone number removed)].

Thank You.

Job Type: Permanent

Job ID: 255046669