Penumbra US Alameda, CA, USA
Sep 12, 2019
Providing critical support for Penumbra’s clinical trials, you will prepare SAS programs to enable the preparation and statistical analysis of clinical data. You will coordinate the statistical programming activities for multiple clinical projects and partner with other programmers, statisticians, and clinical data managers in the collection, analysis, and reporting of clinical data for trials. This is a contract position planned to last a duration of 6-12 months. The job Independently lead and perform all statistical programming activities for your projects. Creating the clinical trial data sets and programs for regulatory submissions and ensuring their accuracy. Help develop the SAPs for our clinical studies and interpret statistical analysis plans to develop analysis and data set specifications. Determine scope of peer reviews and ensure that the accuracy of the SAS programs by reviewing the output, code, and log files. Maintain expertise in the use of SAS Macros, formulate proposals and create new SAS macros while maintaining existing Macros. Identifying opportunities for productivity improvements and figuring out implementation plans. Serve as statistical programming SME, providing specific expertise on timeline development, identification of statistical programming deliverables and resource requirements helping create, review, and maintain project timelines and monitor progress of statistical programming activities. Interact with data management, biostatistics, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors. Mentor other statistical programmers and monitor their performance. Provide input into SOP reviews and write effective SOP's on statistical programming. What you bring The desire to take on complex challenges and work with a great team. Bachelor’s or Masters degree in Statistics, Computer Science, or a similar quantitative field with a minimum of 7-12 years or relevant experience of combined educational and job experience. Competence in SAS programming and Macro development. Experience with clinical trials, including familiarity with expectations of regulatory agencies, FDA preferred. Ability to interpret statistical analysis plans to develop analysis data set specifications. SAS Certified Base and/or Advance Programmer experience preferred. Excellent oral, written, and interpersonal communication skills. Attention to detail and the ability to handle multiple tasks. What we offer A collaborative teamwork environment where learning is constant and performance is rewarded. The opportunity to be at the forefront of technology 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 medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics 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 P 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.