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Posted in

Consulting

Job Code

1728833

Statistical Science Director - Biostatistics - Pharma

Domnic Lewis Private Limited (TechnoScience).12 - 25 yrs.Bangalore
Posted today
Posted today

We are looking for a Senior Clinical Trial Statistician / Biostatistics leader to drive statistical strategy across Clinical drug development.

- Experience as a Clinical Trial Statistician / Biostatistician

- Strong Pharma / Healthcare / Clinical Development experience

- Experience contributing to Clinical Development Plans & Clinical Trial Protocols

- Strong Statistical Analysis Plan (SAP) experience

- Experience with Regulatory Interactions / Submissions

- Expertise in Sample Size Calculation & Simulation

- Experience with Bayesian Inference / Advanced Statistical Methodology

- Strong Early Clinical Development experience

- Hands-on SAS and/or R experience

- Ability to translate statistical evidence into drug-development decisions

- Strong communication, stakeholder management and program leadership skills

Responsibilties:

- Lead statistical strategy across the product development lifecycle, from preclinical development through regulatory and commercial stages.

- Drive statistical input into study design, protocols, SAPs, data interpretation and regulatory submissions.

- Partner with cross-functional teams to assess benefit-risk, value and uncertainty and support critical product development decisions.

- Provide strategic and technical leadership to internal and external statisticians, including mentoring and capability development.

- Lead engagement with CROs, health authorities, advisory boards, payers and external scientific communities.

- Drive statistical methodology innovation, including adaptive designs, Bayesian approaches and other advanced methodologies.

- Represent Statistics in internal governance and senior leadership forums, influencing portfolio progression and investment decisions.

- Lead strategic projects and/or methodological advancements that establish enterprise-wide statistical standards.

- Strong opportunity to influence enterprise-level statistical strategy and decision-making.

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Job Views:  
8
Applications:  2
Recruiter Actions:  0

Posted in

Consulting

Job Code

1728833

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