Principal Statistical Programmer

• 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 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.

Do you have experience in Regulatory submissions?, Do you have a Bachelor’s degree?, * Minimum 8 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.

• Education Requirements (degree, certifications, etc.): Include must have and preferred

BS/MS in Statistics, Math or Scientific Discipline.

From $66.81 an hour - Contract