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    Job · 20856011

    Domnic Lewis Private Limited (TechnoScience) logo

    Statistical Science Director - Biostatistics - Pharma

    Domnic Lewis Private Limited (TechnoScience) · Bengaluru · onsite · Posted 51d ago

    Undisclosed12–25 yrsfulltimeSourced fromIIM Jobs

    About a minute. You'll make an account on the way through.

    About this role

    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.

    Sourced from iimjobs

    Skills

    statisticsBiostatisticsSAS

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