Associate Director, Biostatistics — Lead Global Trials

SUN PHARMA; Princeton (NJ); On-site; USD 187,000 - 207,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Disability insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Paid vacation and sick time

Job summary

Sun Pharma is seeking an experienced Associate Director of Biostatistics to join our rapidly growing organization in Princeton, NJ. This role will lead statistical activities across registration-directed clinical trials and global regulatory submissions, partnering with cross-functional teams to ensure regulatory compliance and high-quality analyses.

Reporting to a Director, Biostatistics Lead, you will help develop standards, review AdaMs and TFLs, and contribute to innovative trial designs and

Qualifications

• PhD or MS in Biostatistics or Statistics required.
• Strong knowledge of Phase I–IV drug development.
• Proficient in SAS and R; experience with regulatory submissions a plus.
• Experience with NDA/BLA submissions and eCTD is advantageous.

Responsibilities

• Serve as study biostatistician on development programs and multiple studies.
• Author statistical analysis plans, TFL shells and other study-related documents.
• Review AdaM Specifications, oversee AdaMs and TFLs, ensuring timely, high-quality deliverables.
• Plan and implement statistical analyses; provide input to clinical study reports and submission activities.
• Provide statistical support for Health Authority requests, publications, and conference materials.
• Contribute to methodological innovations and trial design; perform simulations to compare design options.

Skills

Statistical analysis principles

Phase I-IV drug development knowledge

Analytical thinking

Education

Ph.D. in Biostatistics or Statistics

Tools

SAS

R

eCTD knowledge (NDA/BLA)

Job description

Sun Pharma is seeking an experienced Associate Director of Biostatistics to join our rapidly growing organization in Princeton, NJ. This role will lead statistical activities across registration-directed clinical trials and global regulatory submissions, partnering with cross-functional teams to ensure regulatory compliance and high-quality analyses.

Reporting to a Director, Biostatistics Lead, you will help develop standards, review AdaMs and TFLs, and contribute to innovative trial designs and