Uncubed
           

Senior Statistician

Penumbra, Alameda, CA

Innovative Medical Devices


As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
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What You'll Work On

  • Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
  • Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
  • Review Data Management Plan and study design specifications.
  • Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
  • Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
  • Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
  • Assist in the writing of publications resulting from the studies.
  • Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
  • Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
  • Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
  • Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group

What You Bring

  • An appreciation for complexity, combined with a passion for clean, accurate data.
  • Master's degree or higher in statistics, mathematics or a related field.
  • The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
  • Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
  • Excellent oral, written, and interpersonal communication skills.
  • Working knowledge of computer programming and software programs (e.g., SAS, R) required.
  • Understanding of FDA regulatory requirements and ICH/GCP preferred.

What We Offer

  • A collaborative teamwork environment where learning is constant and performance is rewarded.
  • The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
  • A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

About Penumbra

PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Penumbra

Want to learn more about Penumbra? Visit Penumbra's website.