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 teams, 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.
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 recent 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.
Experience:
Minimum 5 years Pharmaceutical/Biotech programming experience.
NDA submission experience and knowledge required.
Solid 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 Statistics, Math or Scientific Discipline.