Associate Director of Biostatistics

3 days ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
About Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a global revenue of over $5.1 billion, we provide high-quality, affordable medicines to customers and patients worldwide.

Our company has a rich history, dating back to 1983, and has grown to become one of the largest generic pharmaceutical companies in the world. We are committed to innovation and excellence, with a strong R&D focus and a global presence in emerging markets.

Job Description

We are seeking an experienced Associate Director of Biostatistics to join our team. This role will be responsible for supporting the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.

The successful candidate will work closely with internal departments and external resources to ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs). They will apply technical expertise to the development of biostatistics standards and procedures, and contribute to the development and implementation of innovation in statistical methodology and trial design.

Responsibilities
  • Support the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.
  • Work closely with internal departments and external resources to ensure adherence to relevant regulatory requirements and company SOPs.
  • Apply technical expertise to the development of biostatistics standards and procedures.
  • Contribute to the development and implementation of innovation in statistical methodology and trial design.
  • Plan and implement statistical analyses, provide statistical input to the clinical study report, and perform statistical functions for submission-related activities.
  • Provide statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia.
  • 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.
Requirements
  • Ph.D. or M.S. in Biostatistics or Statistics.
  • 10+ years of experience in biostatistics, with a strong 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.
What We Offer

As a member of our team, you will have the opportunity to work with a talented group of professionals, contribute to the development of innovative medicines, and enjoy a comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program.

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan.

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