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Quantitative Scientist in Medicine

2 months ago

Tucson, Arizona, United States Critical Path Institute Full time
~~~~~~~Remote based position

ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit organization dedicated to fostering partnerships and innovative methodologies that enhance human health by streamlining the development and approval processes for new therapies. For over a decade, we have collaborated with industry and academic leaders to advance technologies across the medical product development continuum, from research to regulatory endorsement. As a prominent nonprofit entity committed to promoting collaboration and data sharing in the precompetitive space, C-Path has spearheaded numerous initiatives aimed at expediting the delivery of new treatments to patients. Our ongoing success is supported by a blend of public and private contributions from those who share our vision of accelerating the journey to a healthier world.

POSITION OVERVIEW

The Quantitative Medicine (QuantMed) Program at Critical Path Institute (C-Path) is focused on the advancement and innovation of quantitative methodologies for medical product development and clinical applications. We are seeking intellectually curious and innovative professionals for the role of Quantitative Medicine Scientist. The primary objective of this position is to enhance QuantMed's existing capabilities in modeling and simulation to support drug development initiatives. The Quantitative Medicine Scientist will contribute to QuantMed project deliverables in pharmacometrics and statistics, particularly concerning neurodegenerative disorders such as Alzheimer's disease. This role offers the opportunity to collaborate with leading experts and key opinion leaders within C-Path's extensive scientific network.

SUPERVISORY RESPONSIBILITIES

None

CORE DUTIES and RESPONSIBILITIES
  • Develop and implement pharmacometric and statistical methodologies, along with advanced quantitative pharmacology strategies, to inform drug development for various neurodegenerative diseases.
  • Guide disease progression prediction strategies by integrating mathematical functions and scientific pathophysiological principles, in collaboration with disease-expert program leads to facilitate data-driven decision-making.
  • Evaluate and apply nonlinear mixed effects (NLME) modeling, Bayesian inference, multivariate modeling, causal inference, and other quantitative techniques as necessary for drug development decision-making.
  • Represent the QuantMed Program and provide subject matter expertise on cross-functional project teams.
  • Foster and maintain collaborative relationships with colleagues at C-Path.
  • Stay updated on and implement new techniques in quantitative medicine, clinical pharmacology, modeling, and simulation.
  • Author, review, and approve modeling and simulation analysis plans and outputs, interpreting and presenting key findings to regulators and stakeholders as required.
  • Contribute technical input for statistical and pharmacometric reports and regulatory submissions.
  • Ensure compliance with established timelines and budgets to guarantee timely and accurate execution of deliverables.
  • Provide training within and outside the QuantMed Program as necessary.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

To excel in this role, the individual must effectively perform each essential duty. The requirements outlined below represent the knowledge, skills, and abilities necessary. The Quantitative Medicine Scientist must be adept at identifying various quantitative methods and selecting the most suitable approach based on analytical considerations, disease-specific knowledge, and available data. Effective communication skills are essential for participating in modeling work group discussions within C-Path-coordinated public-private partnerships with external stakeholders. Strong writing abilities are necessary to contribute to the scientific content of manuscripts, posters, grants, and other external communication materials. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Programming Skills:
  • Proficient in R and the tidyverse ecosystem.
  • Experienced in running modeling and simulation applications on Linux platforms.
  • Skilled in version control workflows using git.
  • Familiarity with 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.
  • In-depth knowledge of statistical modeling, particularly regression techniques, null hypothesis significance testing, trial design, power analysis, and sample size estimation.
  • Proven ability to manage multiple scientific analysis deliverables and priorities through matrix management and leadership.
  • Experience collaborating with cross-functional project/program teams in life sciences is advantageous.
  • Experience with large-scale multivariate models for neurodegenerative disorders such as Alzheimer's disease and/or Parkinson's disease is preferred.
  • Experience contributing to statistical analysis plans and/or biomarker qualifications for clinical studies is a plus.
  • Familiarity with Bayesian data analysis is beneficial.
Language Ability:
  • Excellent oral, written, and virtual communication skills.
Reasoning Ability:
  • Strong critical thinking and analytical skills.
  • Technical problem-solving abilities.
  • Sound judgment when handling critical or confidential information.
Physical Demands:
  • Regularly required to sit for extended periods and occasionally stand and walk.
  • Regularly uses hands to operate computer and office equipment.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, and lift (up to 25 pounds).
  • Occasional travel for out-of-town meetings (~ 10%).
REQUIRED EDUCATION and EXPERIENCE
  • Doctoral or equivalent degree in statistics or a related field with 1+ years of relevant research or development experience, or
  • MS or MA in statistics or a related field with 4+ years of relevant statistical research or development experience.
Critical Path Institute is an equal opportunity employer. Visit our website for more information.

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.