About this role
<h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.</span></h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Job Overview</span></h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">The Statistician will provide excellence and expertise in statistical support to the site in order to drive the application of advanced and state-of-the-art statistical principles, tools, and methodologies with the goal of improving process understanding, product quality, and compliance, as well as driving efficiency, process capability, and profitability.</span></h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Main Responsibilities</span></h1> <ul> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">With supervision and guidance, provide technical support to Quality, Program Management, Product Development, Process Development (Manufacturing Sciences, Analytical Sciences), Manufacturing, Manufacturing Engineering, Supply Chain, and Regulatory & Compliance with hands-on analysis of process and product data. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Apply appropriate routine and advanced statistical methods in order to improve and to maintain optimal process control and product compliance, with limited guidance from the Senior Statistician. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Explain and justify application of statistical methods to internal and external regulatory bodies and health authorities. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Actively support PD activities and participate in the Global Statistics network.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Implement LEAN strategies for data collection, data management, reporting, etc.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Develop and lead statistics trainings to applicable departments. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Develop and implement statistics-focused quality operating procedures, work instructions, forms, and templates.</span></li> </ul> <h1 style="margin:0.0in 5.0pt 8.0pt 0.0in;line-height:12.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in 5.0pt 8.0pt 0.0in;line-height:12.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Process development and design transfer</span></h1> <ul> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support the design of characterization, qualification, validation, test method development (TMD), test method validation (TMV), equivalence/comparability, stability studies, and other studies.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Analyze and interpret data from characterization, qualification, validation, test method development (TMD), test method validation (TMV), equivalence/comparability, stability studies, and other studies.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support design and tech transfer activities by providing study designs and acceptance criteria that demonstrate comparability of transferred processes and product quality.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support the construction and interpretation of failure mode and effects analysis (FMEA) and fault tree analysis (FTA). </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Design experimental studies to evaluate criticality of inputs and to predict outputs with confidence. Select optimal parameters by evaluating DOE results through ANOVA, PLS regression, and other relevant models. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support products throughout the life cycle, from characterization à qualification à validation à commercial.</span></li> </ul> <h1 style="margin:0.0in 5.0pt 0.0in 0.0in;line-height:12.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in 5.0pt 0.0in 0.0in;line-height:12.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Product and process monitoring and controls</span></h1> <ul> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Apply modeling and simulation techniques to define and support the process control strategy.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Define, describe, calculate, and apply process capability indices and studies, including identifying characteristics, specifications, and tolerances.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Distinguish between natural process limits and specification limits.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Calculate percent defective and future risk. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Assess processes through the implementation of monitoring and statistical process control (monitoring plans and reports, establishing commercial control limits). </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support the compilation of Annual Product Reviews (APRs).</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Define sampling plans that are in line with the site’s sampling strategy, including defining, describing, and applying the concepts of producer and consumer risk, operating characteristic (OC) curves, acceptable quality limits (AQL), and rejectable quality limits (RQL).</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Define sampling plans that are in line with the site’s qualification sampling strategy in order to qualify and challenge process controls by establishing failure rates.</span></li> </ul> <h1 style="margin:0.0in 5.0pt 8.0pt 16.0pt;line-height:12.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in 5.0pt 0.0in 0.0in;line-height:12.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Data-driven decision making</span></h1> <ul> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Select, construct, apply, and interpret tools such as flowcharts, pareto charts, cause and effect diagrams, control charts, check sheets, scatter diagrams, and histograms and support implementation.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support the analysis of complex data sets to facilitate root cause investigations by offering data-driven decisions.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Calculate and interpret standard error, tolerance intervals, confidence intervals, and equivalence intervals. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Apply and interpret the concepts of significance level, power, type I, and type II errors. </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Define and distinguish between statistical and practical significance.</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support Key Performance Indicators (KPIs) tracking/monitoring.</span></li> </ul> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Skills and Qualification</span></h1> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <ul> <li><span style="font-size:18.0pt;line-height:115%;font-family:arial, helvetica, sans-serif;color:black">Bachelor’s Degree required, preferably in Statistics, Mathematics, Engineering, or another relevant branch of study</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="line-height:115%;color:black">3+</span><span style="line-height:115%;color:black"> years of relevant experience </span></span></li> <li><span style="font-size:18.0pt;line-height:115%;font-family:arial, helvetica, sans-serif;color:black">Proven experience in data science and applied statistics, e.g., in DOE and multivariate data analysis including regression and ANOVA. </span></li> <li><span style="font-size:18.0pt;line-height:115%;font-family:arial, helvetica, sans-serif;color:black">Proficiency with statistical software, e.g., JMP, Minitab, SPSS, SAS, R.</span></li> <li><span style="font-size:18.0pt;line-height:115%;font-family:arial, helvetica, sans-serif;color:black">Proficiency in Microsoft Office (Word, Excel, PowerPoint).</span></li> <li><span style="font-size:18.0pt;line-height:115%;font-family:arial, helvetica, sans-serif;color:black">Effective communication (written and verbal) and collaboration within cross-functional teams.</span></li> </ul> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"> </span></h1> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">We Offer</span></h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <ul> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Competitive compensation package</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Modern working environment with state-of-the-art facilities and technologies</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Challenging assignments in a fast growing and innovative industry </span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Position in a dynamic, international team of highly skilled professionals</span></li> <li><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Various opportunities for personal and professional development within a global organization</span></li> </ul> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.</span></h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </h1> <h1 style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">For more information on SHL Medical, please visit: shl-medical.com</span></h1>