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Km80.5

Principal Statistical Analyst (CDISC Specialist)

Pharmacyclics, Inc.

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Location: Sunnyvale, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: 37-HC-7 Required Education: Bachelors Degree

Description

Description:


General Position Summary/Purpose:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.



Key Accountabilities/Core Job Responsibilities:
•Project lead level activities.
•Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
•Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
•Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
•Review Data Management Plan, Data validation plan and edit check specifications
•Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
•Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.  
•Recognizes inconsistencies and initiates resolution of data problems.
•Acts as a liaison between statistical computing, subcommittees and project teams as needed.  
•Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
•Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
•Acts independently to determine methods and procedures on new assignments.
•May provide guidance to other lower level personnel.

Requirements

Qualifications:
•Ability to use professional concepts to achieve objectives in creative and effective ways.
•Experience in the analysis of complex Oncology clinical trial data.
•Experienced in supervising and mentoring programming staff.
•Solid knowledge of CDISC standard (SDTM & ADaM).

Experience:
•Minimum 10 years Pharmaceutical/Biotech programming experience. Understanding of Oncology Clinical trials knowledge required.
•NDA submission experience is a plus
•Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.

Education Requirements (degree, certifications, etc.): Include must have and preferred
•BS/MS in Scientific Discipline.
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