Statistician

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.

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.

• 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.
• 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.
• Explain and justify application of statistical methods to internal and external regulatory bodies and health authorities.
• Actively support PD activities and participate in the Global Statistics network.
• Implement LEAN strategies for data collection, data management, reporting, etc.
• Develop and lead statistics trainings to applicable departments.
• Develop and implement statistics‑focused quality operating procedures, work instructions, forms, and templates.

• Support the design of characterization, qualification, validation, test method development (TMD), test method validation (TMV), equivalence/comparability, stability studies, and other studies.
• Analyze and interpret data from characterization, qualification, validation, test method development (TMD), test method validation (TMV), equivalence/comparability, stability studies, and other studies.
• Support design and tech transfer activities by providing study designs and acceptance criteria that demonstrate comparability of transferred processes and product quality.
• Support construction and interpretation of failure mode and effects analysis (FMEA) and fault tree analysis (FTA).
• 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.
• Support products throughout the life cycle, from characterization à qualification à validation à commercial.

• Apply modeling and simulation techniques to define and support the process control strategy.
• Define, describe, calculate, and apply process capability indices and studies, including identifying characteristics, specifications, and tolerances.
• Distinguish between natural process limits and specification limits.
• Calculate percent defective and future risk.
• Assess processes through the implementation of monitoring and statistical process control (monitoring plans and reports, establishing commercial control limits).
• Support the compilation of Annual Product Reviews (APRs).
• 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).
• 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.