Associate Director, Biostatistic

1 month ago

Princeton NJ United States Sun Pharmaceutical Industries, Inc. Full time

Company: Sun Pharmaceutical Industries, Inc (USA)

The Company

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries.

Position Summary

Sun Pharma is seeking an experienced and motivated Senior Principal Statistician or Associate Director of Biostatistics to join our rapidly growing organization. Reporting to the Senior Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions.

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 the 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.
  • Adhere to departmental and regulatory agency procedures and standards.

Required Qualifications

  • 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.
  • Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel.
  • Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

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