Viatris
10,000+ employees
Founded 2020
đź’Š Pharmaceuticals
⚕️ Healthcare Insurance
Pharmaceuticals • Healthcare Insurance
Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.
Principal Statistician
Job not on LinkedIn
đź•’ June 12
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Viatris
10,000+ employees
Founded 2020
đź’Š Pharmaceuticals
⚕️ Healthcare Insurance
Pharmaceuticals • Healthcare Insurance
Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.
đź“‹ Description
• Take a leading role in designing clinical studies • Guide statistical strategy and ensure statistical deliverables meet standards • Partner closely with clinical science, clinical operations, regulatory teams, and external CROs • Support late-stage drug development across multiple therapeutic areas • Act as a key advisor within project teams • Ensure statistical integrity and innovation throughout the product lifecycle • Provide statistical leadership for indications or compounds • Serve as the primary statistical authority for pivotal clinical trials and regulatory submissions • Respond to health authority queries and represent Viatris in statistical discussions • Partner with clinical and medical teams to drive evidence-based decisions • May act as a subject matter expert in internal governance and external scientific forums • Confidently apply advanced modeling techniques • Lead statistical oversight for outsourced studies • Ensure compliance with ICH guidelines, GCP, and regulatory requirements • Lead integrated analyses, meta-analyses, and data exploration • Contribute to publications and publication strategy
🎯 Requirements
• MSc or PhD (preferred) in Statistics, Biostatistics, or related field • Extensive involvement in late-phase trials and regulatory submissions • Significant level of relevant experience within Pharmaceutical Company or a CRO • High level of expertise in statistical inference, experimental design, and clinical trial methodology • Strong understanding of ICH guidelines and regulatory requirements • Solid understanding & implementation of CDISC requirements for regulatory submissions • Strong written and oral communication skills with the ability to effectively explain methodology, and associated decision making, to non-statisticians • Ability to prioritize, with strong time management skills, and to be pro-active • Experience in oversight of CRO statisticians (either from within a Sponsor organization or via a senior role within the CRO) • Proven experience and strong track record of contributing to FDA/EMA drug approvals • Expert proficiency in SAS and/or R (experience with both is a plus)
🏖️ Benefits
• Friendly working atmosphere • Competitive salaries • Benefits • Excellent career progression opportunities • Work-life balance initiatives
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