Associate Director – Associate Principal Statistician, Quantitative Sciences Consultant
Organon
full-time
Posted on:
Location Type: Hybrid
Location: Oss • 🇳🇱 Netherlands
Visit company websiteJob Level
Senior
About the role
- 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 standardization 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.
Requirements
- 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.
- Excellent programming skills in R.
- A collaborative spirit, pragmatic mindset, and strong English communication 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 analyze (bio)processes, (bio)assays and development of analytical methods with strong knowledge of regulatory requirements.
- 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.
Benefits
- Professional development opportunities
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysesR programminggeneralized linear mixed modelsdesign of experiments (DoE)statistical process controlsimulationbioassaysanalytical methodsroot-cause analysisrisk assessment
Soft skills
collaborative spiritpragmatic mindsetstrong communication skillsproblem-solvingnetworking
Certifications
MScPh.D.