Law

HI,
PLEASE SEND RESUMES TO GVINOD@ADDONUSA.COM

Duration: 12+ Months

 

My Pharmaceutical client requires a talented, proactive, and highly motivated individual to provide statistical programming support for clinical studies and regulatory submissions. You will hold a senior position influencing the running and management of the whole biometrics department.

 

Requirements:

• 5+ years of experience using SAS in the pharmaceutical or biotech industry

• 2+ years of experiences programming tumor response related efficacy endpoints for phase II or III oncology clinical trials

• Expertise in SAS/BASE, SAS/STAT, SAS/MACRO

• Competence with SAS/GRAPH, SQL

• Experience with regulatory reporting and submissions; involvement in NDA or BLA is preferred

• Understanding of regulatory requirements and considerations (e.g. GCP, ICH, 21CFRpart11, CDISC)

• Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science or equivalent work experience

• Excellent organizational, technical, and interpersonal skills

• Ability to work independently and act with initiative to address issues

• Conscientious and efficient approach to program writing, validation and organization

• Fluent oral and written English

THANKS,
VINODREDDY

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