Senior Manager, Biostatistics

6 days ago

Princeton NJ 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 SPARC. 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 lifecycle of the study. The main activities would include review of the Protocols, eCRF, SDTM/ADAM specs review, SAP authoring, DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission. This is a hands-on position, requiring deep knowledge of statistical methods, willingness to learn new approaches, and ability to implement new statistical approaches in clinical research.

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, 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-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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