ECLARO ยท 2 months ago
Statistician
New Brunswick, NJ
Contract
Hybrid
Mid Level
$66/hr - $66/hr
3+ years expECLARO is a leading global biopharmaceutical organization dedicated to discovering, developing, and delivering innovative medicines. The Statistician will support various functions including development, process improvement, and regulatory responses by applying statistical methodologies and providing data-driven insights across company operations.
Staffing & Recruiting
Hiring Manager
Froilyn Jane Bautista
Responsibilities
Collaborate with stakeholders to identify statistical needs and apply appropriate methodologies
Partner with Manufacturing, Manufacturing Science & Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvement
Support Quality Control and Analytical Sciences & Technology teams in method lifecycle management and reference standard qualification, including development, validation, and investigations
Develop and implement statistical approaches for study design and data analysis to ensure batch compliance and reduce risks of rejection or recall. This may include specification setting, process capability, sampling plans, and product shelf life (expiry/retest periods)
Perform thorough statistical analyses, provide data-driven insights, and recommend actionable solutions aligned with business needs
Represent the statistics function at product development, product protocol, and management meetings
Contribute to the improvement and standardization of processes, procedures, and systems related to statistics while maintaining flexibility where required
Promote statistical awareness and process control competency across the organization through training and development
Foster a shared commitment to quality and compliance at every level
Demonstrate professionalism, collaboration, and a commitment to quality in daily responsibilities
Qualification
Required
MS in Statistics, Biostatistics, Applied Mathematics, or related field with 2+ years of experience, or PhD with no additional experience
3+ years of experience applying statistical methodologies such as linear regression, ANOVA, Design of Experiments (DoE), mixed models, and multivariate analysis
3+ years of experience using statistical software (e.g., JMP, SAS, R, or Python)
1+ year of data analysis experience in the biopharmaceutical industry
Strong communication skills and the ability to explain statistical techniques to non-statisticians
Ability to manage multiple projects in a dynamic environment
Preferred
Experience in biopharmaceutical development and manufacturing, especially with CMC statistics
Familiarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distribution
Knowledge of statistical process control, variance component analysis, and Bayesian methodology
Company
ECLARO
ECLARO is an award-winning professional services firm headquartered in New York City and operating in the U.S., Canada and the Philippines.
1001-5000 employees
H1B Sponsorship
ECLARO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (2)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Nicholas Butcher
QA CTO Label Specialist
Dan Broderick
Chief Delivery Officer
Company data provided by crunchbase