Job Description

Responsibilities:

Process Electronic Data Capture (EDC) data into analytical datasets.

Create Tables, Listings, and Figures to support Regulatory Clinical Trials.

Develop and maintain SAS programs for data importing, quality assurance, and reporting.

Produce Define XML/PDFs, aCRFs, and Reviewers Guides to support SDTMs and ADaMs.

Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy.

Create, document and validate macros at the table, listing and figure level

Maintain PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities.

Trouble-shoot and resolve programming issues in a timely and efficient manner.

Perform the following tasks per project specific timelines under supervision, as deemed appropriate to level.

Set- up standard programming directories and start-up utilities.

Requirements:

Bachelor's degree in mathematics, Statistics, Biostatistics, Epidemiology, or related scientific field.

3+ years of experience with statistical programming in the CRO, medical device, or pharmaceutical industry is required.

SAS certified preferred.

Experience and familiarity with medical devices is highly preferred.

Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros.

Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.

Strong knowledge of data standards for clinical research and statistical analysis including CDISC SDTM, ADaM, and ICH Statistical Principles for Clinical Trials.

Thorough understanding of relational database components and theory

Excellent application development skills.

Job Tags

Permanent employment,

Similar Jobs