Statistical Programmer Analyst

Location : Hayward, CA

Term      : 6months Contract


Primary Skills: SAS Programming( macro programming, data null),validation
programming,data management

Responsibilities:

   - 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



   - Bachelor's degree required, advanced degree preferred.
   A minimum of 4 years of experience as a statistical analyst using SAS in
   a pharmaceutical environment.
   *Advanced skills in SAS programming language, especially data null, macro
   programming, data step programming and report writing*.
   Knowledge of and proven ability to utilize advanced statistical
   procedures in SAS, e.g., LIFETEST, MIXED, GLM.
   A minimum of 4 years of SAS statistical analysis for ISS/ISE and NDA
   submissions.
   Experience with ISS/ISE and NDA submissions in paper and electronic or
   eCTD form.
   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

Kumar
IT Staffing
E-Mail: [email protected]
URL: www.itstaffing.net

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