SAS Programmer Analyst

Responsibilities:
* Develop SAS (Statistical Analysis Software) programs to analyze and report the data generated from clinical trials, quality and improvement initiatives and various ad-hoc analytical studies.
* Develop programs and provide mapping specifications based on study design to create datasets and define data definitions and metadata.
* Check the conformance of SDTM datasets against CDISC standards.
* Provide submission preparation and QC support for dataset section of eCTD backbone and to ensure submission readiness.
* Write user-defined, general purpose SAS MACROS.
* Generate programs to validate output reports, assist in the specification, development and validation of standardized modules, reports, and tables for FDA and international regulatory submissions.
* Customize statistical data output into reports, graphs, tables and listings utilizing up-to-date SAS PROCEDURES and tools in both UNIX and Windows environments.
* Write SAS programs to develop data summaries to analyze & generate tables and graphs, perform model selections and create front-end windows.
* Program for ISS/ISE and prepare analysis datasets.
* Program and document eSubmission and NDA filings.

Education / Professional experience
* Bachelor's or preferably Master's or equivalent degree in Biostatistics, Statistics, Epidemiology, Mathematics, Computer Science, Life Sciences or related field
* 5+ years of pharmaceutical experience
* Proven experience in NDA submissions, especially creation of pooled SAS datasets for integrated analysis of safety and integrated analysis of efficacy
* Good interpersonal, communication, problem solving, and analytical skills
* Expert technical skills in SAS Base/Macro/Graph
* Excellent experience in high-level efficient SAS programming
* Excellent knowledge of CDISC-compliant SAS data structures (SDTM, ADaM, DDT) and other related regulatory guidance
* Knowledge of Excel, ACCESS and other statistical software such as S-Plus, SPSS, and etc is a plus

Send me an updated resume ASAP!! REFERRALS WELCOME!!
'' or call 212-707-8499

Thanks
Paul

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