Statistical Science Director Domnic Lewis Pvt. Ltd

5.0 - 9.0 years

0 Lacs

karnataka

On-site

As the Statistical Science Director at our organization, you will play a crucial leadership role in advancing the application of statistical science within the pharmaceutical industry. Your extensive experience in statistical methodology, project design, delivery, and interpretation will be instrumental in guiding various stages of product development. Your responsibilities will include leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The ideal candidate for this role is recognized externally as an expert in statistical methods and possesses the ability to guide complex analyses while mentoring junior staff. Strong cross-functional collaboration skills are essential for success in this position. Your key responsibilities will involve project leadership, where you will lead statistical design and strategic planning for product development across preclinical studies, regulatory strategies, health technology assessments, and commercial applications. You will oversee statistical content development to ensure high-quality study design, documentation, analysis delivery, interpretation, and regulatory submission. Additionally, you will be responsible for quantifying and communicating the benefit-risk profile, value, and uncertainty associated with emerging product data. As the Statistical Science Director, you will provide leadership across global teams, direct the work performed by internal statisticians and external partners, and manage partnerships with CROs to ensure timely and high-quality deliverables. Staying current with statistical methodologies and promoting the adoption of innovative approaches will also be a key part of your role. You will present statistical strategies and recommendations at internal governance forums and mentor and coach statisticians to contribute to their technical development and training. In terms of technical and methodological leadership, you will be expected to demonstrate deep knowledge of technical and regulatory requirements in pharmaceutical and healthcare settings. You will lead the implementation of novel statistical methodologies into applied practice and contribute to or lead regulatory interactions and submissions from a statistical perspective. Building and maintaining strong collaborative relationships through excellent communication will be essential. Your goal will be to achieve national or international recognition as a statistical expert through speaking engagements, publications, and external collaborations, serving in a technical leadership capacity to guide the direction and delivery of work across teams. To qualify for this role, you should have an MSc or PhD in Statistics, Mathematics with a strong statistical component, or an equivalent degree. You must have proven ability to lead statistical activities independently across complex projects and possess exemplary technical and analytical skills with a track record of delivering impactful statistical strategies. A PhD in Statistics or a related discipline is typically required, along with being a recognized expert in statistical methodology and demonstrating leadership in technical areas. Desirable attributes include therapeutic area or disease-specific expertise, exposure to business development activities, project management capabilities, and proficiency in statistical programming languages such as SAS, R, and Python.,

Posted 6 days ago

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