Statistical Programmer- SAS

Description


 

Core Responsibilities:

*Coordinates, programs, analyzes, and evaluates clinical data.

*Relies on extensive experience and judgment to plan and accomplish goal.

*Analyze, write, test, run and maintain programs to generate databases, SAS datasets, ASCII files, etc., to be transferred to the FDA as required.

*Analyze, write, test, run and maintain computer programs for reporting of data from external sources into the clinical database system.

*Prepare data listings, tables, and graphical displays of data in the database as required to support data reviews, statistical analysis and report writing efforts on a projects.

*Maintain appropriate documentation files of all programs used to process data for a project. *Prepare data listings, tables and summaries of data in the clinical database to support adverse experience regulatory reporting. Performs others tasks required as necessary to meet the needs of the business.

*Review CRF's and ensure their design meet the protocol criteria and contain all data required to support a high quality database and the planned analysis.

*Develop programming specifications for derived data sets, listing tables and summary tables in the collaboration with Study Statistician.

*Create test data and create derived data sets.

*Develop and participate in programming development and validation of programming needed for above.

*Participate in data review and provide feedback on data quality.

*Maintain appropriate study documentation files, data set, program and output log files.

*Perform other non-statistical adhoc requests, patient profiles, QA edit checks.

*Review data for adherence to protocol, consistency in handling and coding, completeness, accuracy, and relevance of final data sets.



Requirements


Qualification: *The candidate should have a minimum of a Bachelor's degree with at least 10 years SAS programming experience, at least 6 of which represent experience in clinical trials data processing. Knowledge of rational databases and Pl/SQL and familiarity with Windows/Windows NT network environment considered a plus. Experience in Proc SQL and Oracle Clinical data extracts necessary. *The candidate should be able to understand and carry out detailed instruction. Candidate should be attentive to detail, flexible, open to suggestions and possess good communication skills. Candidate should be able to interact with staff from multiple departments-clinical, safety, computing, etc.-to establish project standard.

 

Technical: Data Validating and Updating: *Interfaces Clinical, Safety, Biostatistics Database administration personnel to resolve problems and issues dealing with clinical data, and clinical database. *Instructs Clinical staff in the proper use of the database, and statistical software. *Ensures that all the SOP's, policies and procedures are followed in regards to the clinical database and software. *Validates the completeness, accuracy and consistency of the clinical database on an ongoing basis through the use of ad hoc summary computer generated reports and listings. *Designs, test and implements clinical data validation and derivation procedures in the Clinical Data management system. *Performs on-line review of automated validation/consistency checks for accuracy and appropiateness for the Clinical data process. *Documents errors, omissions, inconsistencies found during the clinical database validation process. *Performs other tasks required as necessary to meet the needs of the business. *Responsible for enforcing Clinical Data integrity.