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PenumbraSenior Statistical Programmer Analyst - T
Penumbra seeks a Senior Statistical Programmer Analyst to join its team. In this position, the professional will prepare analysis programs to support the preparation and statistical…
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About This Role
Penumbra seeks a Senior Statistical Programmer Analyst to join its team. In this position, the professional will prepare analysis programs to support the preparation and statistical analysis of clinical data, working alongside biostatisticians, data managers, and other programmers. The role involves playing a leading part in collecting, analyzing, and reporting clinical trial information. Penumbra is a global healthcare company headquartered in Alameda, California, that designs, develops, manufactures, and markets innovative…
Job Description
Penumbra seeks a Senior Statistical Programmer Analyst to join its team. In this position, the professional will prepare analysis programs to support the preparation and statistical analysis of clinical data, working alongside biostatisticians, data managers, and other programmers. The role involves playing a leading part in collecting, analyzing, and reporting clinical trial information.
Penumbra is a global healthcare company headquartered in Alameda, California, that designs, develops, manufactures, and markets innovative medical products aimed at treating challenging conditions with significant unmet needs. The organization sells its portfolio to hospitals and healthcare providers via its direct sales organization in the United States, Australia, Canada, and much of Europe, as well as through international distributors.
This role suits an experienced statistical programmer with a strong background in the medical device, pharmaceutical, biotechnology, or contract research organization sectors who possesses deep knowledge of CDISC standards and regulatory submission requirements. The position involves a general office environment with approximately ten percent travel required for conferences or visits to affiliated company sites.
Responsibilities
- Develop algorithms and write programs to create datasets following established specifications
- Produce, independently check, and maintain data listings, summary tables, and graphs using analysis software
- Import and export clinical data
- Assist the data management group with data edit checks to support data cleaning
- Maintain knowledge of CDISC guidance documents, FDA electronic submission regulations, and industry trends
- Prepare clinical trial datasets and programs intended for regulatory submission
- Write specifications for analysis datasets following the statistical analysis plan
- Collaborate with project statisticians and fellow project team programmers
- Manage the data warehouse utilized for storing clinical study data libraries
- Coordinate with regulatory affairs, quality assurance, and external clinical system vendors
- Mentor less experienced statistical programmers
- Act as the subject matter expert on CDISC and good statistical programming practices
- Build efficient SAS coding and macro libraries
- Ensure all work complies with GCP, ICH, 21 CFR part 11, internal SOPs, and the company Quality Management System
- Oversee that department members adhere to quality system regulations, standards, and procedures
Requirements
- Bachelor’s degree in Statistics, Computer Science, or a related field
- At least 5 years of statistical programming experience
- At least 3 years of clinical statistical programming experience within the medical device, pharmaceutical, biotechnology, or CRO industry
- Proficiency in Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT
- Strong understanding of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology
- Expertise in utilizing SAS for data import, data manipulation, data analysis, data export, and generating graphs
- Proficiency in developing SAS/MACROS to access, extract, modify, merge, and analyze clinical data
- Strong oral, written, and interpersonal communication skills with a high degree of accuracy and attention to detail
- Proficiency with MS Word, Excel, and standard office tools
Qualifications
- SAS Certified Base and/or Advanced Programmer credential
- Experience with macro programming and SAS/SQL
- Knowledge of international regulations and guidance associated with clinical data standards and databases for regulatory submissions
- Experience with clinical data metadata repositories
- Experience contributing to regulatory submissions
- Familiarity with clinical data management systems such as Oracle InForm or RAVE
Core Skills
Benefits
- Medical, dental, vision, life, and AD&D insurance
- Short-term and long-term disability insurance
- 401(k) plan with employer match
- Paid parental leave
- Eleven paid company holidays per year
- Minimum of fifteen days of accrued vacation per year, which increases with tenure
- Paid sick time in compliance with applicable law
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the hourly base pay range for this position?
The hourly base pay range is $65.00 to $115.00, with individual compensation varying based on factors such as qualifications, skill level, competencies, and work location.
What are the travel requirements for this role?
The position requires approximately 10% travel to conferences and/or other Penumbra affiliated facilities.
What education and experience are required to apply?
Applicants must hold a Bachelor’s degree in Statistics, Computer Science, or a related field, along with at least 5 years of statistical programming experience, including a minimum of 3 years in clinical statistical programming within the medical device, biotechnology, pharmaceutical, or CRO industry.
What benefits are provided to eligible employees?
Eligible employees receive medical, dental, vision, life, AD&D, short and long-term disability insurance, a 401(k) with employer match, paid parental leave, 11 paid holidays, at least 15 days of accrued vacation annually, and paid sick time.
Sample Interview Questions
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