*send resumes to [email protected]

*

*Clinical SAS Programmer *

*Location: Hayward, CA*

*Duration: 6 Months*



Skills:

Description:

•Support Biostatisticians, writers and clinical staff in statistical
analysis, including generating data summaries, listings, tables, figures and
ad-hoc reporting.
•Support Data Management in database creation, transfers, integrity checks,
and audits.
•Validation of programming code used to produce tables and data for
submissions to regulatory agencies.
•Ensure completeness, correctness and consistency of clinical data and data
structure.
•Assist in defining and validating company specific CDISC data standards for
clinical study reports and regulatory submissions.
•Work closely with statisticians on dataset specifications and programming
details.
•Review clinical study protocols and CRFs

*Requirements/Qualifications:*

•Bachelor's degree required, advanced degree preferred.
*•A minimum of 2 years of experience as a statistical programmer using SAS
in a pharmaceutical or CRO environment.*
•*A minimum of 2 years of SAS programming for ISS/ISE and NDA submissions.*
•*Experience with ISS/ISE and NDA submissions in paper and electronic or
eCTD form.*
•Advanced skills in* SAS programming* language, especially *data null, data
step programming and report writing.*
•Knowledge of advanced statistical procedures in SAS, e.g., *LIFETEST,
MIXED, GLM.*
•Significant knowledge and hands-on experience in *CDISC/SDTM* standards.
•Good working knowledge of *ICH, FDA, and GCP* regulations and guidelines.
•Ability to multi-task and effectively set own priorities, while maintaining
accuracy and attention to detail.
•Good problem solving skills.
•Must have excellent verbal, written and interpersonal communication skills.

*
*

*Thanks & Regards,*

*Shravan kota*

*Astir IT Solutions, Inc.*

*Ph:* 908.548.0791 * *

*Fax:* 973-215-2191          *Email : **[email protected]*

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