Associate Director, Biostatistics

About 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

Benefits