AbbVie Sr. Principal Statistical Analyst in Sunnyvale, California
Sr. Principal Statistical Analyst
USA, California, Sunnyvale
Research & Development
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us athttp://www.pharmacyclics.com/
General Position Summary/Purpose:
Provide programming support for multiple clinical projects across multiple therapeutic areas through own effort and those of their staff. Accountable for providing Statistical Programming support for multiple therapeutic areas.
Key Accountabilities/Core Job Responsibilities:
Demonstrate extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations.
Oversee effort to determine and implement global company standards related to output design and programming conventions.
Responsible for monitoring regulatory guidance and industry best practices.
Provide strategic guidance on the development of CRFs and database designs.
Provide in-depth critical review of global standards related to CRF designs and database designs.
Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications.
Oversee effort to determine and implement global company standards related to SDTM and ADaM.
Demonstrate an understanding of drug development principles.
Anticipate potential problems within and across projects and develops appropriate contingency plans.
Create escalation plans to ensure resolution of all issues at the therapeutic and project levels.
Participates in and is viewed as a key contributor to cross functional initiatives.
Effectively and persuasively present statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists.
Effectively present information through planning and execution of meetings and presentations
High degree of technical competence and strong communication ability, both oral and written.
Highly competent in SAS programming and Macro development.
Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience.
Thorough understanding of ICH Guidelines and relevant regulatory requirements.
Understand CDISC standards and applicability to clinical database design/capture and reporting.
Knowledge in integrating SAS with other leading technologies such as Extensible Markup Language (XML), Microsoft Office, etc. to support electronic submissions.
Knowledge of Pinnacle 21.
Understand about reviewer’s guides and Define.xml. Education and Experience:
MS in Statistics, Computer Science, Bioinformatics, Biostatistics, or a related field with 10+ years of relevant experience; OR BS in Statistics, Computer Science or a related field with 12+ years of relevant experience.
Significant Work Activities and Conditions: Routine work with chemicals
Job Type: Experienced
Job Level Code: M