Health It Consultant

This is a remote position.
Must be a US Citizen or Permanent Resident. If a Permanent Resident, they must have resided in the U.S. for a total of at least three (3) of the past five (5).
Scope:
The scope of this statement of work includes the range of activities necessary to promote the efficient and technologically advanced review and analysis of DHT data. FDA recognizes the potential for DHTs to provide scientific and practical advantages in supporting the assessment of patients by generating information outside of the traditional clinic visit and needs to build capacity and expertise to advise the biopharmaceutical industry in their development and implementation and to evaluate DHT outputs including the impact of regulatory initiatives (or regulatory science). The task order will enable reviewers to assess product safety, efficacy, and quality by enhancing the capacity to review submissions with DHT-derived data. FDA will build technical expertise within the human drugs and biologics program to enhance internal knowledge, capabilities for review of IND- and NDA/BLA submissions including DHT derived endpoints, policy, standards and guidance development. FDA will develop and improve staff capacity to evaluate DHT-derived data through the development of training materials on study designs using DHT-derived endpoint, appropriate statistical methods for evaluation of DHTs proposed as measuring efficacy and safety endpoints in clinical trials, summarization of DHT data and handling of missing data.
Training Task Description:
As tasked, the team shall develop and execute a specialized training strategy that will provide the FDA reviewer and analyst community with advanced skills necessary to analyze DHT data consistently and appropriately. As tasked, the team shall plan, develop, and deliver training. The training deliverable will be recorded and retained for future use by FDA. The team shall evaluate, track, and measure training programs (courses, material, etc.) for effectiveness in meeting business goals and objectives. It is expected that the team is well versed in multiple training development and delivery modalities to meet needs of the FDA community.
The training course should include, but not limited to the following topics:
Overview
In general, what do statisticians need to know and want to know about DHT data?
Design and data collection:

• What is a good endpoint for DHT? When should a DHT be used to capture an endpoint? PRO?
• What is the advantage of continuous measurement?
• How to determine the minimum time required for a DHT device to be active?
• What constitutes a minimum valid DHT data set?
• How to sample an event?
• For sampling interval - how to determine the frequency of measurements needed to capture the concept of interest and estimate the summary measure with sufficient precision?
• How to select a range of a relevant questions and provide meaningful summary measures, and determining a clinically meaningful difference in such measure (threshold level)?
• When designing a study with intensive longitudinal measurements
  • How is this study different from other types of studies where there are no intensive measurements (e.g. number of subjects; length of follow-up; intensity of follow-up)? What stays the same (e.g. randomization; control group; etc.)?
  • What are the operating characteristics of trial designs using DHT-derived endpoint?
  • How to compute power and sample size?

Analysis:

• What are the commonly used statistical methods to analyze DHT data, and when should these methods be applied?
• How to define missing data? How to handle missing data?
• Measurement error: discrepancies in measurement against an accepted standard for one device
  • Examples: gait measured by video vs DHT, lab values vs CGM,
• Agreement/concordance/correspondence in measurement between different devices
  • Continuous measurement agreement?
  • Summary measure agreement?

Miscellaneous:

• Viewpoints on different devices used in the same study
• Issues seen:
  • Transmission errors
  • Data standards
  • Updates in software

Specific Responsibilities of the Health IT Consultant - Skill Level V:

• Act as a subject matter expert for DHTs for the project team and FDA statistical reviewers.
• Lead all trainings for FDA reviewers.

Note: Other team members will be responsible for creating the training plan and training materials.
Required skills/Level of Experience:
The subject matter expert must possess the following qualifications:

• PhD in Statistics/Biostatistics/Mathematics or related fields
• Expertise in methods for wearable device research, especially focusing on accelerometers/actigraphy and/or ecological momentary assessment (EMA)
• Substantial experience with a variety of statistical techniques, including but not limited to longitudinal analyses, state space approach, point process modeling, functional data analysis, and functional regression.
• Excellent communication skills
• At least 12 years of exp
• Microsoft Excel
• Microsoft Word
• Excellent verbal and written communication skills

Nice to have skills:

• Experience working with both the Clinical Data Interchange Standards Consortium (CDISC) and the FDA and is familiar with the interaction between these groups;
• Familiar with the Office of Biostatistics review environment;
• Working knowledge of the Study Data Tabulation Model (SDTM);
• Experience with the development of Analysis Data Standards; and
• Expertise in the Analysis Data Model (ADaM).

Note that the 'nice to have' skills are not required; other team members with these skills can bridge any gaps for the subject matter expert related to data standards and FDA regulatory review processes.