Associate Director / Principal Statistician – Quantitative Sciences Consultant

Associate Director / Principal Statistician – Quantitative Sciences Consultant 

 
This position is ideally located at our manufacturing sites in Oss (The Netherlands) or Heist- op-den-Berg (Belgium). 

The position 

By joining the Center for Mathematical Sciences (CMS) as an Associate Director / Principal Statistician – Quantitative Sciences Consultant, you will be part of the Organon Manufacturing & Supply (OMS) organization, making a real difference in ensuring a compliant, predictable and robust supply of medicines to patients. Additionally, you take part in our team’s mission to transform the manufacturing division’s way of performing data driven decision making. 

In this role, you will drive quantitative analyses for the most important and complex non-clinical projects in OMS globally, including root-cause analyses, improving product and process robustness, supporting shelf-life evaluations, validation of (bio)assay and (bio)processes, reference standard qualifications, tech transfers, regulatory filings or commercialization related projects. You will serve as a statistical expert and partner in decision making, often collaborating closely with the CMS team. 

The Center for Mathematical Sciences (CMS) team 

Our team is strongly positioned within Science & Technology – a subdivision of the OMS organization with representation of various Technical Operations groups and other support areas providing integrated end-to-end support. Being part of the CMS team, you will be exposed to the non-clinical side of the product lifecycle and will support the organization from late-stage development to commercial supply on both projects with a compliance focus or with an improvement emphasis. These projects can be related to drug substance, drug product, packaging or equipment related challenges. In this way you get exposure to diverse quantitative challenges and simultaneously build a strong internal and external network. 

We believe our team should be more than a sole provider of quantitative analysis (mostly statistical) and is both effective in structuring problems and able to translate pharmaceutical challenges, that concern data in quantitative solutions. To achieve this as a team, we provide the opportunity to grow as deep statistical expert – especially in areas like biologics, bioassays, and method validation – and/or as broadly effective statistical consultants, ensuring development aligned with each member’s strengths and ambitions. You will join as the fifth member of an energetic team of statistical / quantitative consultants who are based at our manufacturing locations in Oss (NL) and partially in Heist (BE). The team works on site for roughly 60% of the time and the rest from home. In case you live closer to the Heist-op-den-Berg site (Belgium), it is expected that you will visit the Oss site once every other week. Flexibility in working hours is needed occasionally, since global support is provided. 

Responsibilities 

• Independently determine the appropriate statistical complexity in CMS projects – applying practical methods or advanced statistical methods as needed – while recognizing the limitations of each approach. 

• Effectively communicate complex ideas and results to internal customers and mentor CMS team members in the application of complex statistical methods. 

• Translate pharmaceutical questions, generate objectives and hypotheses for data-driven evaluation, and offer decision support through risk assessments and root-cause analyses. 

• Develop and implement innovative statistical methodologies to address specific project requirements or evaluate against (new) regulatory standards. 

• Review the work of other CMS members and ensure accuracy of data used. 

• Build a strong internal and external network to assure continued statistical and mathematical support. 

Required Education, Experience and Skills 

• MSc, or Ph.D. degree in a quantitative discipline (e.g. statistics, mathematics, data science, chemometrics, or any related field). 

• At least six years of relevant industry experience in a statistical consulting role and working with cross-disciplinary teams. 

• Able to effectively explain complex statistical concepts to CMS colleagues and internal customers. 

• A collaborative spirit with strong English communication skills,  

Preferred Experience and Skills 

• Strong background in non-clinical Chemistry, Manufacturing and Control (CMC) statistics, the pharmaceutical industry or a heavily regulated food domain.  

• A proven track-record in applying statistical methods to analyze (bio)processes, (bio)assays and analytical methods. 

• Extensive experience with generalized linear mixed models, DoE, statistical process control, simulation. 

• Proven expertise in problem-solving, transforming business questions into statistical insights, identifying root causes, and recommending effective solutions. 

• Excellent programming skills in R or experience with software like SAS or Minitab. 

• Willingness to further develop in the field of statistics and strong quantitative modelling as well as data analytics.