Job Description

(Bio-)statistical Consultant Non-clinical –Senior Specialist

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 a (bio-)statistical 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, 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.

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 sixth member of an energetic, growing team of statistical / quantitative consultants who are based at our manufacturing locations in Oss (NL) and partially in Heist-op-den-Berg (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 perform statistical analyses related to biological manufacturing (e.g. upstream and downstream processing), bioassays and biological critical reagents.
• Contribute to statistical projects focused on chemical product manufacturing.
• Define the required statistical complexity for CMS projects, using practical or advanced methods as appropriate, while considering their limitations.
• Translate pharmaceutical questions into statistical objectives and hypotheses, perform root-cause analyses, risk assessments, and support to the decision-making process.
• 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.
• Contribute to developing strong relationships with internal customers 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 two 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 or experience with software like SAS, Minitab or Python.
• A collaborative spirit with 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 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.
• Willingness to further develop in the field of statistics and strong quantitative modelling as well as data analytics.

Secondary Job Description

Who We Are:

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.

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.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R537019