Role Description

We are seeking a highly motivated individual to join the Non-Clinical and Diagnostics Statistics group with experience in one or more areas of experimental design, regression, multivariate statistics, AI/ML, quality control, Bayesian methods and simulation. The qualified applicant will work broadly across the company in diagnostics and device development, analytical chemistry, pharmaceutical development, discovery and biomarker development and CMC.

The successful candidate will work in close partnership with laboratory scientists, engineers, and others to develop and implement fit-for-purpose study designs, experimental plans and analyses to enable robust data-driven decision making and timely delivery of project objectives. Willingness to understand laboratory methods, device, vaccine and biopharmaceutical development, discovery and biomarker development, and CMC processes in order to better communicate, partner with and educate colleagues is essential.

The candidate will be expected to lead statistical aspects of discovery and development activities spanning diverse teams at various stages including product discovery, development, devices, validation, and commercialization. They will also provide guidance on data collection and retrieval and may need to work with teams to develop systems/programs to allow individual scientists to generate their own visualizations and analyses where appropriate.

The colleague will need to also support submission related activities spanning non-clinical development processes such as, but not limited to, assay and process development/validation, specifications. Our department is highly collaborative, and colleagues are expected to actively participate in group meetings and follow standard departmental procedures.

The successful candidate must have excellent communication skills, the ability and desire to work with large, complex teams of scientists, and have the ability to work across multiple projects simultaneously. This role requires cross site support and occasional travel may be required.

Education:

PhD in Statistics (or related field with extensive training in statistical methods), preferably 2+ years industry experience
MS in Statistics (or related field with extensive training in statistical methods) with 4+ years of industry experience

Essential Skills and Attributes:

Knowledge of data handling, statistical analysis and programming in PC-SAS, JMP and R.
Experience with, but not limited to, statistical design and analysis of experiments, QbD, assay/process validation, data visualization.
Experience working in, but not limited to, one or more areas in developing/validating: medical devices, pharmaceutical products, assay technologies (e.g., PCR, genetic assay technologies, HPLC, etc), robust processes, and robust formulation.
Experience and a desire to mentor and coach early in career peers.
Experience leading teams through complex issues to address business needs.
Excellent oral and written communication and statistical consulting skills.
Ability to critically review scientific publications.
Highly organized, able to manage multiple simultaneous projects and significant attention to detail.
Works well in a team environment and consistently follows standard operational practices.
Champion the use of established and innovative statistical methods across the entire organization.
Desire and curiosity to learn about the science and business.

Desirable Skills and Attributes:

Direct experience with statistical aspects of diagnostics kit development and validation in addition to a strong understanding of regulatory considerations in the diagnostics space is highly desirable.
Knowledge and/or experience with CMC regulatory requirements for diagnostic and/or pharmaceutical products.
Regulatory interaction experience (e.g., submissions, audits, inspections, responses).
People manager/team leader experience.

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors.

Base Pay Range: $89,000 - $128,000

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and
other factors.

Base Pay Range: $100,000 - $144,000

[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.]

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.

Full time

Regular

Colleague

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