Senior Manager, Biostatistics

Job Grade

Senior Manager

Location:

Hybrid at Gurugram or Mumbai

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

JOB DESCRIPTION

Sun Pharma is seeking an experienced and motivated Senior Manager of Biostatistics to join our rapidly growing organization. Reporting to the Senior 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 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.