DURECT's compensation package includes a competitive salary, stock options, comprehensive benefits package, along with a dynamic corporate culture and supportive team environment.
Job Title: Sr. SAS Programmer
Location: Cupertino, CA
Description:
Perform in-house statistical programming, data management and analysis.
MAIN DUTIES AND RESPONSIBILITIES
· Management of database transfer process and database specifications for various DURECT projects in collaboration with outside vendors for the purpose of providing in-house data management and analysis.
· Creation of derived data specifications based on statistical analysis plan.
· Creation of SAS programs for clinical trials data summary and analysis.
· Production of derived data sets for safety and efficacy.
· Production and summarization of clinical trials data (tables, listings and graphics).
· Creation of internal DURECT capability to maintain, summarize, and analyze clinical trials data.
· Preparation of statistical regulatory documents in anticipation of various FDA/MAA submissions and briefing packages (eminent work).
Requirements:
KNOWLEDGE / EDUCATIONS
- M.S. or PhD. in Statistics or related field
JOB EXPERIENCE
- At least 5 years of Biopharmaceutical or CRO experience
- Regulatory Submission (NDA/BLA) expereince
- Must be fluent in SAS programming, particularly CDISN/SDTM
- Must have previous experience filing eCTD drug registration with FDA
- Familiarity with the preparation of regulatory documents such as Intergrated Safety Summary and Intergrated Summary of Efficay is required
SKILLS / COMPETENCIES
- Excellent verbal and written communication
- Collaborative skills in team settings are required
- Must be able to work independantly and be proactively resourceful
WORKING CONDITIONS
- Work will be performed primarily in an office environment involving computer intesive tasks
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