Job Category: Pharmaceutical & Biotech

Sr. Manager, Statistical Methods (DG)

Job Location: Northern, NJ (see all jobs in NJ)

Work Type: Remote

Date Posted: 2022-09-06

Sr. Manager, Statistical Methods - Northern, NJ (Remote)
160-170K base + bonus and LTI
North NJ based company

The Senior Manager, Statistical Methods is an expert in statistical methodology within the GCA Statistics team who will provide leadership in statistical methods and strategy and consult with clinical statisticians in providing innovative statistical solutions for clinical and non-clinical projects across all businesses. Be part of something bigger!

One of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Provide leadership in developing strategic quantitative frameworks for clinical projects in close collaboration with clinical statisticians and clinical team. Support regulatory interactions or external engagements with objective and transparent strategic assessments using quantitative risk and success assessments. Provide strategic statistical scientific consultation and quantitative contributions to regulatory submission strategy and related activities. Provide leadership in identifying opportunity, foster and drive the full integration of modern statistical methodology including model-based innovative study design. Provide support in advanced decision making to senior management using modern statistical techniques. Identify and promote risk-mitigation combining quantitative methodology and disease knowledge. Provide leadership in fostering the integration of Statistical Methodology. Make sure that the GCA team including statistics, data management, medical and scientific writing and other functions are aligned from the statistical scientific perspective. Interact with Health Authorities and external key opinion leaders as the recognized statistical expert. Provide support to the interaction and partnership between the GCA statistics team and the business units. Ensure close cooperation in identifying and defining analytical needs and generating business insights and evidence. Work on internal and external databases for evidence generation and drive innovation via the use of data driven insights. Provide technical statistical expertise, leadership and serves as a mentor to junior statisticians.

The position reports to the Senior Director, Statistics and Data Management, Global Clinical Affairs.

Expert-level statistical knowledge including Bayesian statistics demonstrated in facilitating and optimizing the clinical development strategy. Track record for scientific leadership in the development and evaluation of modern trial design methodology. Ability to work on issues of diverse scope and which may involve multiple geographies, where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, medical practice and regulatory issues. Ability to program in at least one statistical programming language, such as R or SAS, is required. Ability to credibly represent a Business or function to external stakeholders, such as business partners, regulatory authorities, and key customers is required. High level of organizational savvy is required. Ability to exercise strong professional judgment is required. Ability to serve as a role model within the organization is required. Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are critical.

A minimum of a PhD degree required in Statistics, Biostatistics, or related field.

6+ years of working experience with 2+ years of experience in a regulated healthcare industry is required.

Please contact Darren Gutowski at

160-170K base + bonus and LTI

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