3 Statistical Methodology Jobs

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same. Job Description Your role The Packaging Engineer will be responsible for supporting designing, developing, and implementing packaging and labeling materials for US/OUS medical devices. The individual should have good understanding of Packaging standards and Compliance requirements (ASTM, ISTA, ISO 11607 and EU-MDR). Within this context the activity will focus on: The job requires a self-motivated individual with collaborative skills on project, process with limited supervision. The individual should be a team player who is willing to collaborate. Fully participates in and successfully contributes to project teams typically including the following activities: Packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation. Generate, evaluate and coordinate packaging related documentation including specifications, test plans/reports, and other BSC Product Development Process documents. Strong knowledge of statistical methodology. Evaluate, create and document package/product test methods for new product development and existing design improvements. Understanding of documentation management systems and good manufacturing practices (GMPs) is required. Work closely with other members of the Packaging Engineering department and interact with personnel from a variety of areas within BSC. Develop strong team skills, including communication, teamwork, initiative and managed execution of all project deliverables. Work with suppliers and OEM contacts to establish partnerships to maximize quality, delivery, and lead times, and to incorporate their abilities, ideas, and material/product knowledge into new development. Keep abreast of new technologies, test methods and advances in the medical device packaging industry Your profile Bachelor's Degree in Packaging Engineering or Equivalent Engineering Degree Minimum 2-6 years work experience Experience with MS tools (Excel, Word, PowerPoint, etc.) Experience with Statistical Software and its use for Engineering Applications Knowledge of Supply Chain / Product Distribution practices What You'll Love About Working Here We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance. At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities. Equip yourself with valuable certifications in the latest technologies such as AWS and Microsoft Azure. Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

Generate, evaluate and coordinate packaging related documentation including specifications, test plans/reports, and other BSC Product Development Process documents. Strong knowledge of statistical methodology. Evaluate, create and document package/product test methods for new product development and existing design improvements. Understanding of documentation management systems and good manufacturing practices (GMPs) is required. Work closely with other members of the Packaging Engineering department and interact with personnel from a variety of areas within BSC. Develop strong team skills, including communication, teamwork, initiative and managed execution of all project deliverables. Work with suppliers and OEM contacts to establish partnerships to maximize quality, delivery, and lead times, and to incorporate their abilities, ideas, and material/product knowledge into new development. Keep abreast of new technologies, test methods and advances in the medical device packaging industry. Academic Qualification and Experience Bachelor s Degree in Packaging Engineering or Equivalent Engineering Degree Minimum 4-6 years work experience Experience with MS tools (Excel, Word, PowerPoint, etc.) Experience with Statistical Software and its use for Engineering Applications

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.,