Senior Scientist, Biostatistics, CMC Statistics

Job Description

In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enable the discovery development regulatory approval manufacturing and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This job description outlines the responsibilities primary activities educational requirements and skills needed for a biostatistical leadership role in drug development particularly within the Chemistry Manufacturing and Controls (CMC) Statistics area in biologics.

Responsibilities

The role involves providing biostatistical leadership and support for drug development projects in CMC area coordinating with various internal groups such as analytical formulation project management regulatory statistical programming data management and manufacturing divisions. The individual serves as a statistical lead in project teams managing multiple projects independently and supporting scientific protocols. They represent the statistical function in cross-functional teams and contribute to department and therapeutic area goals. Participation in professional societies and technical associations is also expected.

Primary Activities

Key activities include acting as the statistical representative and lead in cross-functional teams for strategic planning and product development execution. The role requires developing data analysis plans and selecting appropriate statistical methodologies to analyze and interpret data from CMC-related studies. Preparing reports to communicate results to project teams management regulatory agencies or scientists is essential. Additionally mentoring junior staff is part of the responsibilities.

Education and Minimum Requirement

Candidates should hold a PhD or equivalent degree in statistics biostatistics or a related field. Alternatively a Masters degree in Statistics or Applied Statistics with at least three years of relevant experience is acceptable.

Required Skills and Experience

The role demands knowledge of statistical analysis methodologies and experimental design including mixed models variance component analysis equivalency studies nonlinear regression and Bayesian analysis. Proficiency in statistical software such as JMP SAS and/or R is required. The individual should demonstrate the ability to learn proactively be motivated detail-oriented and capable of working independently. Strong communication skills and effective collaboration across functions are also necessary.

Preferred Skills and Experience

An understanding of disease biology and drug discovery and development is preferred for this position.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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