Associate Director, Biostatistics
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Upload Your ResumeAbout This Role
This role involves supporting the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions within Sun Pharma's Biostatistics department. The Associate Director will work cross-functionally and apply technical expertise to develop biostatistics standards and procedures.
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 orientated work environment, building partnerships and modeling teamwork
Requirements
- 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
- Excellent organizational skills, time management, and ability to coordinate workload
- Excellent verbal and written communication skills
- Attention to detail and quality
Qualifications
- Ph.D. or M.S. in Biostatistics or Statistics
Nice to Have
- NDA/BLA experience with eCTD submission
- Dermatology or oncology drug development experience
- Broad experience in an emerging, publicly traded company environment
Skills
* Required skills