Principal Biostatistician FSP - Chemistry, Manufacturing and Control

Cytel • Lincoln, NE • 1w ago

Who Are You?

An experienced Biostatistician with in-depth Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls (CMC) data analysis. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

We are seeking a highly motivated Biostatistician to support CMC projects across the drug development lifecycle. The ideal candidate will have a strong foundation in statistical methodologies and programming and will play a critical role in analyzing complex manufacturing data to ensure product quality, consistency, and regulatory compliance.

As a Principal Biostatistician, your responsibilities will include:

Provide statistical support for CMC-related studies, including formulation development, stability studies, process validation, and analytical method validation.

Collaborate with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs, to develop and implement appropriate statistical strategies.

Design and analyze experiments using linear mixed models, particularly for stability and variability analyses.

Perform statistical modeling, data visualization, and simulations using R programming.

Experience with Bayesian methods preferred.

Ensure quality and compliance with internal standards and regulatory guidelines (e.g., FDA, EMA, ICH).

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

Required Qualifications:

M.S. or higher degree in Biostatistics, Statistics, or a related quantitative discipline.

3+ years supporting CMC or related manufacturing/analytical projects in a pharmaceutical or biotechnology setting.

Strong proficiency in R programming for statistical modeling, analysis, and visualization.

Solid understanding and practical application of linear mixed models .

Excellent communication and collaborative skills to work effectively across teams.

Exposure to or hands-on experience with Bayesian statistics and its application in industrial settings.

Preferred Qualifications:

Familiarity with a wide variety of statistical transformations and distributions, appropriate for CMC data.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel

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