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:
- 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.
- Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
- Validate work of other programmer/analysts at CRO or in-house.
- Maintain complete and auditable documentation of all programming activities.
- Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)
- Create/acquire tools to improve programming efficiency or quality.
- Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
- Ability to use professional concepts to achieve objectives in creative and effective ways.
- Experience in the analysis of complex Oncology clinical trial data.
- Solid knowledge of CDISC standard (SDTM & ADaM).
Education Requirements (degree, certifications, etc.):
- Minimum 9 years Pharmaceutical/Biotech programming experience. Experience working with Oncology trials 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.
- BS/MS in Statistics, Math or Scientific Discipline .
Pharmacyclics, Inc. - 21 months ago