Associate Director, Biostatistics

Sun Pharmaceutical Industries Princeton , NJ 08544

Posted 2 months ago

SPARC is seeking an Associate Director of Biostatistics to provide support to Phase 1-3 clinical research studies.

The Associate Director will:

  • Serve as the statistical lead on one or more clinical development programs

  • Engage in planning, methodology, and analysis for Phase 1-3 clinical studies, not limited to protocol development, sample size calculation, authoring of statistical analysis plans, data review, analysis implementation and interpretation

  • Review of case report forms (CRFs), data management plans, data specifications and clinical study reports, creation of randomization schedules, provide statistical analysis and reports to Data Monitoring Committees (DMCs)

  • Work with internal staff and/or vendors to assure that all programming and statistical analyses are completed

  • Provide statistical/programming support for responses to regulatory authorities related to submission reviews

  • Statistical programming/analyses including transfer, creation, conversion, and formatting of SAS data

  • Serve as the statistical representative on cross-funcitonal teams

  • Participate in the development and maintenance of SOPs

Requirements:

  • PhD in Statistics required with 4 or more years of related experience or MS in Statistics with 6 or more years of related experience

  • Expert in SAS programming with demonstrated experience using Base SAS, SAS Stat, macros, analyses and reports

  • Very good written and oral communication skills

  • Great collaborator and ability to work with clinical experts

  • Excellent mathematical skills and problem solving skills

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Associate Director, Biostatistics

Sun Pharmaceutical Industries