Senior Statistical Programmer

Description

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 and SAS export files to 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.
* 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.
* Support lead programmer in generation of analysis datasets, generation of TLFs (Tables, Listings, and Figures), validation of aforementioned data and reports, and maintenance of study documentation
* 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.

Qualifications:

* Ability to use professional concepts to achieve objectives in creative and effective ways.
* Experience in the analysis of Oncology clinical trial data a plus.
* Knowledge of CDISC standard (SDTM & ADaM) a plus.

Experience:

* Minimum 5 years Pharmaceutical/Biotech programming experience.
* 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.):

* BS in Statistics, Math or Scientific Discipline.
To find out more about Real please visit www.realstaffing.com