Associate Director / Associate Principal Statistician …

Associate Director / Associate Principal Statistician - Quantitative Sciences Consultant - Center for Mathematical Sciences (CMS)

Location: Manufacturing sites in Oss (The Netherlands) or Heist-op-den-Berg (Belgium).

Position Overview: By joining the Center for Mathematical Sciences (CMS) as an Associate Director / Associate Principal Statistician – Quantitative Sciences Consultant, you will be part of the Organon Manufacturing & Supply (OMS) organization, supporting the predictable and robust supply of medicines to patients. You will play an active role in transforming the manufacturing division’s way of performing data‑driven decision making.

Role Summary

In this role, you will take a leading role in quantitative analyses for our 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, biological critical reagents, 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.

Responsibilities

• Independently perform or provide guidance to CMS team members in executing statistical analyses related to chemical product manufacturing, biological manufacturing (e.g., upstream and downstream processing), bioassays and biological critical reagents.
• Translate pharmaceutical questions into statistical objectives and hypotheses, perform root‑cause analyses, risk assessments, and support the decision‑making process.
• Define the required statistical complexity for CMS projects, using practical or advanced methods as appropriate, while considering their limitations.
• Effectively communicate complex ideas and results to internal customers and CMS members.
• Ensure that analysis practices remain adherent to (updated) regulatory requirements.
• Review the work of other CMS members and ensure accuracy of data used.
• Guide standardisation and automation of statistical practices by writing packages or coordinating development of small solutions (e.g., RShiny, RMarkdown, etc.).
• Build a strong internal and external network to ensure 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.
• Experienced in effectively explaining complex statistical concepts to customers.
• Excellent programming skills in R.
• A collaborative spirit, pragmatic mindset, and strong English communication skills.

Preferred Experience and Skills

• Experience in the pharmaceutical industry, manufacturing or a heavily regulated food domain.
• A proven track‑record in chemistry, manufacturing & control (CMC) statistics, biostatistics to analyse (bio)processes, (bio)assays and development of analytical methods with strong knowledge of regulatory requirements.
• Extensive experience with generalised linear mixed models, DoE, statistical process control, simulation.
• Experienced with software such as SAS, Minitab or Python and automation of analysis practices (writing packages, RShiny, …).
• Proven expertise in problem‑solving, transforming business questions into statistical insights, identifying root causes, and recommending effective solutions.
• Willingness to further develop in the field of statistics and strong quantitative modelling as well as data analytics.

Company Overview

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of women’s health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our vision is clear: a better and healthier every day for every woman.

Equal Opportunity Employer: As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Employment Details

• Seniority level: Mid‑Senior level
• Employment type: Full‑time
• Job function: Research, Analyst, and Information Technology
• Industry: Pharmaceutical Manufacturing
• Number of openings: 1

Compensation

Annualised salary range: Global — specific to local market and may vary by country.