Senior Statistical Programmer Analyst – T
Penumbra
Opportunity published from Lever · applications stay with the original hiring source.
About the opportunity
Penumbra is seeking a dedicated Statistical Programmer to prepare analysis programs supporting the statistical analysis and preparation of clinical data.
Operating under the general supervision of a Statistics Project Manager or higher, you will collaborate closely with biostatisticians, clinical data managers, and other programmers to play a leading role in the collection, analysis, and reporting of clinical trial data.
This position is based in a general office environment and requires approximately 10% travel to conferences and/or other Penumbra affiliated facilities.
The base pay range is $65.00 to $115.00 per hour, with individual compensation varying based on factors such as qualifications, skill level, competencies, and work location.
Key responsibilities
- Following specifications, develops algorithms and writes programs to create datasets, and produces data listings, summary tables, and graphs using analysis software.
- Independently checks data listings, summary tables, and graphs, and imports and exports data.
- Maintains complete understanding of CDISC guidance documents, implementation guides, and FDA regulations regarding electronic submission of data.
- Prepares clinical trial datasets and programs for regulatory submission, and writes specifications for analysis datasets following statistical analysis plans.
- Manages the data warehouse used to store libraries of clinical study data, and builds efficient SAS coding and macro libraries.
- Acts as the subject matter expert on CDISC and good statistical programming practices, while mentoring less experienced statistical programmers.
- Ensures work is conducted consistent with GCP, ICH, 21 CFR part 11, internal SOPs, and international regulatory requirements.
- Adheres to and ensures departmental compliance with the Company’s Quality Management System (QMS), regulations, standards, and procedures.
Qualifications
- Bachelor's degree in Statistics, Computer Science, or a related field.
- 5+ years of statistical programming experience, including 3+ years of experience in clinical statistical programming within the medical device, biotechnology, pharmaceutical, or Clinical Research Organization (CRO) industry, or an equivalent combination of education and experience.
- Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, SAS/STAT, macro programming, and SAS/SQL.
- Knowledge of international regulations and clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology.
- Expertise in using SAS for Data Import, Data Manipulation, Data Analysis, and Data Export, alongside graph generation capabilities.
- Knowledge of clinical data management systems such as Oracle InForm and/or RAVE.
- Strong oral, written, and interpersonal communication skills with a high degree of accuracy and attention to detail.
- Proficiency with MS Word, Excel, and other standard office tools.
Nice to have
- SAS Certified Base and/or Advance Programmer experience.
- Experience with metadata repositories in clinical data.
- Experience with regulatory submissions.
Base Pay Range Per Hour
$65.00 - $115.00
Work Location
General office environment with approximately 10% travel.
About the company
Penumbra is a global healthcare company focused on innovative therapies. We design, develop, and manufacture novel products that address challenging medical conditions and improve patients' lives worldwide.
Application: UpVagas lists this opportunity from the hiring company or its recruitment platform. The application is completed at the original source.
