Principal Statistical Analyst

At Pharmacyclics, our every effort is directed to bringing new therapies to life: treatments that help people return to the lives they love as quickly and easily as possible. We believe there is nothing more powerful than giving back in this way. We believe there is nothing more valuable than turning hope into reality and allowing people to focus on the splendor in every day. This is what we call the magic of normal—and we want this for as many people as possible.

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.

* 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 programming, 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. * Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP) * Develop SAS coding and table templates for preparing, processing and analyzing clinical data. * Create/acquire tools to improve programming efficiency or quality. * Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. * Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

**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). * BS/MS in Statistics, Math or Scientific Discipline. **Experience:** * Minimum 12 years Pharmaceutical/Biotech programming experience. * NDA submission experience and knowledge required. * Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.