Senior Statistical Programmer Analyst - CDISC & SAS Expert

Remote

San Francisco (CA)

On-site

USD 140,000 - 200,000

Full time

6 days ago
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Benefits offered by this job

Medical, dental, vision
401(k) with employer match
Paid parental leave
Minimum vacation and sick time

Job summary

Penumbra, Inc. in Alameda, California seeks a Senior Statistical Programmer Analyst to prepare analysis programs, develop datasets, and generate tables and graphs for regulatory submissions.

You will work with biostatisticians, programmers, and data managers to ensure data quality and compliance with CDISC and FDA guidelines. The role emphasizes SAS programming, macro development, data management, and mentorship of junior staff, with adherence to GCP/ICH and the company QMS.

Qualifications

  • Bachelor's degree in Statistics, Computer Science or related field with 5+ years of statistical programming experience
  • Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT
  • SAS Certified Base and/or Advance Programmer experience is preferred
  • Experience with macro programming and SAS/SQL a plus
  • Knowledge of CDISC standards and regulatory submission requirements
  • Experience with clinical data management systems e.g., Oracle InForm and RAVE

Responsibilities

  • Following specifications, develops algorithms and writes programs to create datasets
  • Produces data listings, summary tables and graphs using analysis software
  • Independently checks data listings, summary tables and graphs
  • Imports and exports data
  • Maintains understanding of CDISC guidance and FDA regulations for electronic submission of data
  • Prepares clinical trial datasets and programs for regulatory submission
  • Interacts with project statistician and other programmers on the project team
  • Mentors less experienced statistical programmers
  • Builds SAS coding and macro libraries

Skills

Base SAS
SAS/GRAPH
SAS/ODS
SAS/STAT
SAS macros
SAS/SQL
CDISC
CDASH
SDTM
ADaM

Education

Bachelor's degree in Statistics / Computer Science or related field

Tools

SAS
Oracle InForm
RAVE

Job description

Penumbra, Inc. in Alameda, California seeks a Senior Statistical Programmer Analyst to prepare analysis programs, develop datasets, and generate tables and graphs for regulatory submissions.

You will work with biostatisticians, programmers, and data managers to ensure data quality and compliance with CDISC and FDA guidelines. The role emphasizes SAS programming, macro development, data management, and mentorship of junior staff, with adherence to GCP/ICH and the company QMS.

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