Senior Biostatistician

4 weeks ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries Inc. Full time
Job Title: Associate Director, Biostatistics

Sun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company with a strong presence in over 100 countries. We are seeking an experienced and motivated Associate Director of Biostatistics to join our team.

About the Role

The successful candidate will be responsible for supporting the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions. This will involve working cross-functionally with internal departments and external resources on Biostatistics-related issues, ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Key Responsibilities
  • Serve as study biostatistician on development programs and multiple studies.
  • Author statistical analysis plan, TFL shells, and other study-related statistical documents.
  • Review AdaM Specification, oversee the generation of AdaMs and TFLs, and ensure timely high-quality deliverables.
  • Plan and implement statistical analyses, provide statistical input to the clinical study report, and perform statistical functions for submission-related activities on assigned programs.
  • Plan and execute exploratory analyses and statistical consultation within applicable cross-functional teams.
  • Provide statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned.
  • Contribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches.
  • Attend and make statistical contributions at cross-functional study team and project team meetings.
  • Participate in process improvement, SOP development, training, and enhancing statistical technical expertise.
  • Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced, and objective manner.
  • Adhere to departmental and regulatory agency procedures and standards.
Requirements
  • Ph.D. or M.S. in Biostatistics or Statistics.
  • At least 8+ years for PhD (or 10+ years for M.S.) for Associate Director.
  • Demonstrated good understanding of Phase I to Phase IV drug development.
  • Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance.
  • Knowledge of statistical analysis software SAS and R.
  • NDA/BLA experience with eCTD submission is a plus.
  • Dermatology or oncology drug development experience is a plus.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.
  • Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
  • Use teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
  • Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
  • Forward-thinking mindset with the ability to manage multiple projects and identify and resolve issues.
  • Broad experience in an emerging, publicly traded company environment is a plus.

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