Senior Manager, Biostatistics

5 days ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Senior Manager, Biostatistics

This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at Sun Pharmaceutical Industries, Inc. The main responsibilities will include hands-on day-to-day support of one or more clinical studies. The position will provide oversight of all statistical activities during the lifecycle of the study.

Main Responsibilities:
  • Serve as the statistical lead on one or more clinical studies in different phases of development
  • Engage in planning, methodology, and analysis for Phase 1-3 clinical studies, including 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, and provide statistical analysis and reports to Data Monitoring Committees (DMCs)
  • Work with internal staff and/or vendors to ensure 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-functional teams
  • Participate in the development and maintenance of SOPs
Qualifications:
  • PhD in statistics, biostatistics, or related field with 3+ years of clinical development experience; or an MS in statistics, biostatistics, or related field with 5+ years of clinical development experience
  • Demonstrated understanding of the drug development process
  • Demonstrated expertise with clinical trial design, study implementation, statistical methodology
  • Expert in SAS programming with demonstrated experience using Base SAS, SAS Stat, macros, analyses, and reports
  • Strong knowledge and experience with sample size software like PASS, NQUERY, etc.
  • Strong communication (oral and written), presentation, and analytical skills
  • Ability to work independently, prioritize tasks efficiently, and meet expected timelines
  • Ability to interact collaboratively with colleagues, investigators, key opinion leaders, and regulators

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