ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

The Quantitative Medicine (QuantMed) Program at the Critical Path Institute (C-Path) focuses on the development and innovation of quantitative solutions for medical product development and clinical needs. Our team is looking for intellectually curious and innovative thinkers for a position of Quantitative Medicine Scientist. This position's goal is to enhance QuantMed's existing capability in modeling and simulation to support drug development. The Quantitative Medicine Scientist is expected to support QuantMed project deliverables in the areas of pharmacometrics and statistics with focus on neurodegenerative disorders such as Alzheimer's disease. The Quantitative Medicine Scientist will have an opportunity to collaborate with leading subject matter experts and key opinion leaders within C-Path's extensive scientific network.

SUPERVISORY RESPONSIBILITIES

None

CORE DUTIES and RESPONSIBILITIES

• Develop and implement pharmacometrics, statistical, and state of the art quantitative pharmacology approaches to inform drug development for various neurodegenerative disease
• Guide disease progression prediction strategies, incorporating mathematical functions and underlying scientific pathophysiologic principles, in partnership with disease-expert program leads to enable data-driven decisions.
• Evaluate and apply nonlinear mixed effects (NLME) modeling, Bayesian inference, multivariate modeling, causal inference, and other quantitative methodologies as appropriate for drug development decision making.
• Represent the QuantMed Program and provide subject matter expertise on cross‐functional project teams.
• Develop and maintain collaborative working relationship with C-Path colleagues.
• Stay informed about, and devise/apply, new techniques in quantitative medicine, clinical pharmacology, modeling and simulation.
• Author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed.
• Write and provide technical input for statistical and pharmacometrics reports and regulatory submissions.
• Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables.
• Develop and provide training within and outside the QuantMed Program as needed.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required. The Quantitative Medicine Scientist must be competent to identify multiple quantitative methods and choose the most appropriate method based on analytic considerations, disease-specific knowledge, and the available data to base the methods on. The individual should be able to communicate effectively in modeling work group calls within C-Path-coordinated public-private-partnerships with external stakeholders. Strong writing skills are needed to contribute effectively to the scientific content of manuscripts, posters, grants, and other external communication documents. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Programming Skills:

• Proficient in R and tidyverse ecosystem.
• Proficient in running modeling and simulation applications on Linux platforms.
• Proficient in version control workflow using git.
• Experience in NLME tools such as NONMEM and Monolix.

Knowledge/Skill/Abilities:

• Extensive experience in nonlinear mixed effects models (NLME), longitudinal data analysis, and missing data analysis.
• Extensive knowledge in statistical modeling, particularly the regression techniques, null hypothesis significance testing techniques, trial design, power analysis, and sample size estimation.
• Demonstrated excellence in effectively managing multiple scientific analyses deliverables and priorities through matrix management and leadership.
• Experience working with cross-functional project/program teams in life sciences is a plus.
• Experience in working on large scale multivariate models for neurodegenerative disorders such as Alzheimer's disease and/or Parkinson's disease is preferred.
• Experience in contributing to statistical analysis plans and/or biomarker qualifications for clinical studies is preferred.
• Experience with Bayesian data analysis is a plus.

Language Ability:

• Excellent oral, written, and virtual communication skills.

Reasoning Ability:

• Strong critical thinking and analytical skills.
• Technical problem-solving skills.
• Use of sound judgment when working with critical or confidential information.

Physical Demands:

• Regularly required to sit for extended periods of time, and occasionally stand and walk about the facility.
• Regularly uses hands to operate computer equipment and other office equipment.
• Close vision required for computer usage.
• Occasionally required to stoop, kneel, and lift (up to 25 pounds).
• Travel on occasion for out-of-town meetings (~ 10%).

REQUIRED EDUCATION and EXPERIENCE

• Doctoral or equivalent degree in statistics or related discipline with 1 years' relevant statistics research or development experience, or
• MS or MA in statistics or related discipline with 4 years' relevant statistical research or development experience.

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Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Covid-19

All C-Path employees must vaccinate to safeguard the health of our employees and their families and the community at large from COVID-19.

Reasonable Accommodation

Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department.