Associate Director, Biostatistics (India)

Associate Director, Biostatistics (India)

16 Sep
|
Jobgether
|
India

16 Sep

Jobgether

India

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director, Biostatistics based in India.

This role offers an opportunity to provide senior biostatistical leadership across global clinical development programs and registration-directed studies.
You will contribute to clinical trial design, statistical analysis, interpretation, and regulatory submissions from Phase I through Phase IV.
Working across multidisciplinary teams, you will translate complex statistical questions into clear, scientifically sound recommendations.
You will own key statistical deliverables while ensuring quality, regulatory compliance, and timely execution.
The role combines hands-on statistical expertise with opportunities to influence methodology, trial design, standards, and process improvement.
You will collaborate with internal stakeholders and external partners in a dynamic pharmaceutical R&D; environment.
Success requires scientific rigor, robust communication, accountability,



and the ability to manage multiple priorities independently.

Accountabilities

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Serve as the study biostatistician across development programs and multiple clinical studies, providing statistical leadership throughout the study lifecycle.

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Author statistical analysis plans, TFL shells, and other study-specific statistical documentation.

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Review ADaM specifications, oversee the generation of ADaMs and TFLs, and ensure accurate, high-quality, and timely deliverables.

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Plan and execute statistical analyses and provide statistical input into clinical study reports and registration-related activities.

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Conduct exploratory analyses and provide statistical consultation to cross-functional clinical development teams.

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Support responses to Health Authority requests and contribute to scientific publications, presentations, posters, and medical conference materials.

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Provide statistical expertise for clinical trial design,

📌 Associate Director, Biostatistics (India)
🏢 Jobgether
📍 India

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