Senior Statistical Programmer Analyst

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop analysis programs that support the preparation and statistical examination of clinical data.

• Create algorithms and write programs to generate datasets according to specifications.

• Generate and rigorously verify data listings, summary tables, and graphs using analysis software.

• Facilitate the import and export of data.

• Support data management with data edit checks and data cleansing efforts.

• Maintain a comprehensive understanding of CDISC guidelines, implementation manuals, and FDA electronic submission directives and regulations.

• Stay updated on industry trends in data mapping, data management, compliance with standards, metadata management, and data warehousing.

• Prepare clinical trial datasets and associated programs for regulatory submissions.

• Draft analysis dataset specifications in accordance with statistical analysis plans.

• Collaborate with project statisticians and fellow programmers on project teams.

• Oversee the data warehouse utilized for clinical study data libraries.

• Work alongside regulatory affairs, quality assurance personnel, and external clinical system vendors.

• Mentor less experienced statistical programmers.

• Act as a subject matter expert on CDISC and statistical programming methodologies.

• Build SAS coding and macro libraries.

• Conduct work in compliance with GCP, ICH, 21 CFR Part 11, SOPs, training, and regulatory standards.

• Ensure adherence to and assist in maintaining departmental compliance with the Quality Management System and relevant regulations.

• Execute other job-related tasks as assigned.

⛳️ Requirements

• Bachelor's degree in Statistics, Computer Science, or a related field, with over 5 years of statistical programming experience and at least 3 years in clinical statistical programming within the medical device or related industry, or an equivalent combination of education and experience.

• Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.

• Knowledge of international regulations, requirements, and guidance related to clinical data standards and clinical databases for regulatory submissions.

• Understanding of clinical data standards, including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology.

• Experience with clinical data management systems, such as Oracle InForm and/or RAVE.

• Proficiency in using SAS for data import, manipulation, analysis, export, and graph creation.

• Expertise in developing SAS macros to access, extract, modify, merge, and analyze clinical data.

• Strong capabilities in oral, written, and interpersonal communication.

• High level of accuracy and attention to detail.

• Proficiency in MS Word, Excel, and other standard office applications.

• SAS Certified Base and/or Advanced Programmer experience is preferred.

• Experience with macro programming, SAS/SQL, metadata repositories, and regulatory submissions is advantageous.

• Ability to manage multiple tasks efficiently.

• Willingness to travel approximately 10% for conferences and/or other Penumbra affiliated locations.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, AD&D, short-term disability, and long-term disability insurance.

• 401(k) plan with employer matching.

• Paid parental leave.

• Eleven paid company holidays each year.

• Minimum of fifteen days of accrued vacation annually, increasing with tenure.

• Paid sick leave in accordance with applicable laws.

• Collaborative team environment with ongoing learning opportunities.

• Performance-based rewards.

• Opportunity to contribute to therapies for serious diseases.