Senior Biostatistics Director
4 weeks ago
Sun Pharmaceutical Industries, Inc. is seeking an experienced Associate Director of Biostatistics to join our team. This role will support the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.
The ideal candidate will have a strong understanding of Phase I to Phase IV drug development, excellent organizational skills, and the ability to coordinate workload and meet established deadlines. They will also have excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
The Associate Director of Biostatistics will work cross-functionally with internal departments and external resources on Biostatistics-related issues, ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate, and apply technical expertise to the development of biostatistics standards and procedures.
Responsibilities:
- Support the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.
- Collaborate with internal departments and external resources on Biostatistics-related issues.
- Ensure adherence to relevant regulatory requirements and company SOPs.
- Apply technical expertise to the development of biostatistics standards and procedures.
Requirements:
- Ph.D. or M.S. in Biostatistics or Statistics.
- 10+ years of experience in Biostatistics or a related field.
- Strong 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.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
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