Statistical Methodology and Simulation Consultant

  • Contract
  • Remote

SimulStat

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Remote, 6-month contract with extension likely

As a Statistical Methodology and Simulation Consultant, you are expected to use cutting edge modeling and simulation approaches to advance the clinical development of novel drug candidates among our neurology and oncology development programs. You will be responsible for the development and implementation of Statistical Methodology and Simulation strategy. The Statistical Methodology and Simulation activities include disease models, statistical models, simulations for clinical trial planning or analysis, literature meta-analysis, machine learning/deep learning, and other state of the art quantitative techniques. In all efforts, the Statistical Methodology and Simulation Consultant will ensure sound statistical thinking and methodologies are utilized. The successful candidate should be a forward-thinking scientific leader with capabilities to lead collaborative works among diverse teams and create a culture of belonging and inclusion.

Responsibilities and Goals:

  • Key technical responsibilities are to organize, execute, and report statistical methodologies and simulation results independently, as well as to present work at cross-functional teams, department meetings, senior management review committees, regulatory interactions, and scientific conferences
  • Planning, writing, and reviewing relevant clinical documents such as study protocols, analysis plans, reports, and regulatory documents. These will be accomplished by working in close partnership with other scientists including Biomarker Science, Clinical Science, Clinical Operation, Non-clinical Science, Pharmacovigilance, Regulatory
  • Demonstrate project leadership in complicated context, able to influence and engage the strategic, scientific, and technical partners in an agile cross-functional organization
  • Function as a hands-on technical leader, implement best practices while promoting an innovative and data-driven culture
  • Supporting clinical study team including but not limited to generation of data visualizations and summary reports
  • Play key roles on departmental strategic initiatives. Lead or participate in establishing and maintaining Biometrics & Digital Science policies, standards and guidance
  • Ensure up to date knowledge of industry and academic developments in the Immuno-neurology, Immuno-Oncology and Orphan disease fields and apply to clinical study design and analysis
  • Works with Study Biostatisticians and R&D Scientists to assist with innovative trial design, simulation and execution, and develop adaptive trials software tools as appropriate
  • Lead project support requiring hands-on expertise in novel quantitative approaches. This may include: innovative complex clinical trial designs, quantitative decision making, incorporating evidence from trial external sources or big data (e.g. historical data, real world data, biomarkers, digital technology etc.), causal inference etc.
  • Lead collaborative working relationships and effective communication with partners in the Biometrics & Digital Science organization along with other scientists to promote and implement innovative quantitative approaches at project level
  • Implement and communicate innovative quantitative methods to support regulatory submissions and health authority meetings
  • Support the use of advanced analytical support to improve decision making, transition of projects from research to development, quantitative aspects of dose[1]finding, clinical development plan and target product profile, portfolio level evaluation and the assessment of in-licensing opportunities
  • Develop new quantitative methods with the aim of improving drug development in multiple projects. The focus includes clinical trial design and analysis, quantitative decision making, statistical modeling, visualization and machine learning
  • Provide training on quantitative methods to colleagues within the Clinical Development organization

Requirements:

  • Ph.D. or master’s degree in statistics, biostatistics, mathematics, data science, computational biology or another related field
  • At least 8-10 years of proven experience with application of innovative quantitative methods in drug development setting
  • Demonstrated impact on drug development through quantitative approaches. A strong track-record of leadership skills and success in influencing senior leaders is critical for success.
  • Expert knowledge of both theoretical and applied statistics. Strong foundation in probability, statistics, causal inference, and statistical and mathematical modeling
  • Demonstrated ability to work with ambiguous questions, varied and messy data sets, and applying scientific and analytical methods to help inform and drive business decisions and strategies
  • Demonstrated scientific leadership in facilitating and optimizing the clinical development strategy by using expertise in design, modeling or analytics
  • Knowledge of regulatory rules and guidelines applicable to clinical studies, e.g., FDA, ICH, GCP, HIPAA
  • High level of competency using standard statistical software such as SAS, R and/or other relevant statistical modeling and simulation software is required
  • Outstanding interpersonal, communication, and presentation skills as well as demonstrated ability to work effectively in cross-functional project teams.
  • Ability to excel and thrive in a fast-paced, multi-tasked, and hands-on environment.
  • Preferred – expertise in neurology and/or oncology;
  • Preferred – experience delivering on Digital Science projects using predictive technologies, forecasting, and modeling.

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