Associate Director of Biostatistics
4 weeks ago
Sun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a commitment to delivering high-quality, affordable medicines, we have established ourselves as a trusted partner for patients and customers worldwide.
Job SummaryWe are seeking an experienced Associate Director of Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for supporting the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.
Key Responsibilities- Serve as study biostatistician on development programs and multiple studies.
- Author statistical analysis plans, TFL shells, and other study-related statistical documents.
- Review AdaM specifications, 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.
- Ph.D. or M.S. in Biostatistics or Statistics.
- 10+ years of experience for M.S.
- 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.
We provide a competitive compensation package, including a base salary, annual performance bonus, and comprehensive benefits. Our employees also enjoy various paid time off benefits, including vacation time and sick time.
As an equal employment opportunity employer, we welcome applications from diverse candidates and are committed to creating an inclusive work environment.
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