Senior Clinical SAS Programmer & CDISC Lead

Penumbra, Inc.; Alameda (CA); On-site; USD 90,000 - 158,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) with match

Paid time off

Job summary

Penumbra, Inc. in Alameda, CA seeks a skilled Statistical Programmer to design and implement analysis datasets for regulatory submissions. You will develop SAS code, create datasets, and generate listings, tables, and graphs, while ensuring CDISC and FDA guidelines are followed.

The role involves mentoring junior programmers, collaborating with statisticians, data managers, and regulatory teams to ensure data integrity and timely delivery.

Qualifications

• Bachelor's degree and 5+ years in statistical programming; 3+ years in clinical programming within medical devices/pharma/ CRO.
• Familiarity with CDISC standards and regulatory submissions.

Responsibilities

• Develop algorithms and programs to create datasets.
• Produce data listings, summary tables and graphs using SAS.
• Check data listings, tables and graphs for accuracy.
• Import and export data; assist data management with data edits.
• Maintain CDISC guidance, FDA regulations, and industry trends.
• Prepare clinical trial datasets and programs for regulatory submission.
• Write analysis dataset specifications per SAP; mentor junior programmers.
• Act as SME on CDISC and good programming practices; build SAS macros libraries.
• Follow GCP, ICH, 21 CFR Part 11 and internal SOPs; support QMS compliance.
• Collaborate with regulatory affairs, QA, and external vendors.

Skills

SAS Base

SAS Macro

SAS/SQL

CDISC standards

Regulatory knowledge

Data analysis with SAS

GCP/ICH compliance

Communication

Education

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

Tools

Base SAS

SAS/GRAPH

SAS/ODS

SAS/STAT

SAS Macros

SAS/SQL

Oracle InForm

RAVE

Job description

Penumbra, Inc. in Alameda, CA seeks a skilled Statistical Programmer to design and implement analysis datasets for regulatory submissions. You will develop SAS code, create datasets, and generate listings, tables, and graphs, while ensuring CDISC and FDA guidelines are followed.

The role involves mentoring junior programmers, collaborating with statisticians, data managers, and regulatory teams to ensure data integrity and timely delivery.