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Associate Director, Biostatistics

Company

SUN PHARMA

Location

Princeton, United States

Type

Full-time

Sun Pharma is seeking an experienced and motivated Associate Director of Biostatistics to join our rapidly growing organization. Reporting to a 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. This person 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

  • 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 ...
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