Senior Specialist, Associate Statistician

<p><b>Working with Us</b><br/>Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.</p><p></p><p>Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank"><span><span><span><span><span><span><span>careers.bms.com/working-with-us</span></span></span></span></span></span></span></a>.</p><p></p><p></p><p><b><span>Bristol Myers Squibb Ireland</span></b></p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been <span><span><span><span><span><span><span><span><span>awarded “Biopharma</span></span></span></span></span></span></span></span></span> Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great place to Work for Women in 2020, 2021 and 2022.</p><p></p><p><b>Position Summary</b></p><p>The incumbent will provide statistical  analyses and training to support <span>Global Product Development &amp; Supply</span> (GPS) and late stage development to deliver process and method robustness in ensuring product quality and compliance Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses. Support in relation to study design and data analysis will be provided to BMS functions worldwide, including small molecule and biologics development, manufacturing, and supply.</p><p></p><p><b>Major Duties and Responsibilities:</b></p><ul><li><p>Builds and fosters relationships with customers, stakeholders, and support groups globally to understand their statistical needs and determines sound statistical techniques for use.</p></li><li><p>Collaborates with process analytical teams and subject matter experts in Manufacturing and Manufacturing Sciences &amp; Technology to design studies and analyze complex datasets for process robustness and improvement.</p></li><li><p>Supports analytical teams in QC and Analytical Sciences &amp; Technology for method performance monitoring and reference standard qualification.</p></li><li><p>Develops and selects appropriate statistical methods for the design and analysis of studies and programs in order to assure batch compliance and prevent rejections, reworks, complaints, and product recalls on a worldwide basis. For example, determining specifications, process capability, sampling plans and expiry/retest periods.</p></li><li><p>Conducts thorough and careful analysis of data, gathers critical information, and provides appropriate recommendations and solutions based on corresponding statistical analyses and business needs.</p></li><li><p>Demonstrates strong statistical skills while thinking in a clear, decisive manner. Reaches independent, logical solutions.</p></li><li><p>Represents Global Statistics at product development, product protocol, and management meetings.</p></li><li><p>Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required.</p></li><li><p>Furthers the statistical awareness and statistical process control competency of other BMS personnel; participates in their training and development, as required.</p></li><li><p>Acts as departmental interface with Information Technology on system related projects. Performs programming (e.g., SAS) as needed.</p></li><li><p>Creates, communicates, and supports the highest commitment to quality and compliance.</p></li><li><p>Supports the BMS BioPharma Beha