AbbVie Principal Statistical Analyst in Sunnyvale, California
Principal Statistical Analyst
Location: Sunnyvale, CA
# of Openings: 1
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.
General Position Summary/Purpose:
Provide programming support to produce analysis, reports and graphs on all PCYC drugs. Review program codes and suggest alternative solutions that may be efficient. Interact with GRAs, medical writers, clinicians, statisticians, data management and medical affairs personnel, and other members of PCYC R&D. Reports to the site Director, Biostatistics and Data Management and on a dotted line relationship to the Director of Statistical Computing.
Key Accountabilities/Core Job Responsibilities:
Ensure technology updates occur as needed.
Provide programming support to analyze clinical data and generate reports and graphs on all PCYC drugs in the clinical phase.
Hire consultant programmers to meet short-term needs of additional programming resources.
Work with Director of Statistical Computing to establish and ensure adherence with programming and output standards and utilization of systems and processes to maximize efficiency of the statistical programming function.
Lead the development of new processes and provide accurate and timely responses to complex requests from clients and guide clients on possible options for deliverables for non-routine requests.
B.S., M.S. or Ph.D. in statistics, computer science, mathematics or a related field, required.
7 years of experience in the pharmaceutical industry generating analysis , reports and graphs for individual studies and ISS, ISE, NDA submissions to FDA.
Minimum of 2 years of supervisory experience.
Excellent programming skills especially in SAS.
High degree of technical competency and strong communication ability, both oral and written.
Fluency in 2 or more or relevant programming languages, such as R, Python, Perl, Ruby, Java, or C++ required.
Competent in SAS programming and Macro development.
Excellent problem solving, leadership, communication and interpersonal skills.
Working knowledge of current regulatory requirements and guidance.
Demonstrated ability to debug SAS programs and assist programmers.
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 related field with 9+ years of relevant experience; OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled