Attachment 1 - Statement of Work.docx

STATEMENT OF WORK (SOW) SERVICES

Neurodegenerative Disease Scientific Data Analysis Services

GENERAL INFORMATION

Title of Project:

Neurodegenerative Disease Scientific Data Analysis Services

Statement of Need, Purpose, and/or Objective:

The purpose of this requirement is to procure scientific data analysis services related to neurodegenerative diseases in support of the National Institute on Aging (NIA), Center for Alzheimer’s and Related Dementias (CARD).

Background Information:

Alzheimer’s disease (AD) and related dementias have no effective treatments to halt or reverse disease progression. The complexity of these diseases, driven by genetic, molecular, and environmental factors, requires an innovative, data-driven approach to accelerate scientific discovery. Bioinformatics, at the intersection of biology, computer science, and statistics, is a critical tool that empowers researchers to address this challenge. Together, the scientific staff at the National Institute on Aging (NIA) Center for Alzheimer’s and Related Dementias (CARD) will work directly with the contractor’s bioinformatics team on the integration and analysis of large, multidimensional datasets—imaging, genomic, proteomic and transcriptomic data integrated with clinical measurements— to enable the identification of novel drivers of disease pathogenesis, the discovery of biomarkers for stratification and early diagnosis, as well as new therapeutic targets.

The necessity of advanced analytics in Alzheimer’s disease and related dementias research is underscored by the increasing volume and complexity of data generated by new platforms such as spatial transcriptomics and single cell proteomic, epigenetic and transcriptomics. CARD needs a partner in advanced analytics that can keep pace with these new platforms and analytical tools, to uncover insights needed to fully understand the molecular underpinnings of disease. Bioinformatics, analytics and statistics will provide the computational tools to integrate diverse data types, identify patterns and associations that are not readily apparent, and predict disease mechanisms. The contractor must work with the scientific staff to visualize and interpret data. The team will also help foster and lead collaborations across groups within and outside the NIH.

Moreover, the contractor is an essential resource driving group. The team analyzes diverse publicly available datasets and provides insightful interpretations. Advanced analytics also aligns with CARD’s structural priorities, including data democratization, transparency, and reliability, ensuring that Alzheimer’s and related dementias research is inclusive, reproducible, and impactful across the global scientific community. The advanced analytic teams should be capable of designing and implementing solutions that improve data accessibility, quality, and interoperability across the scientific community, ensuring that CARD data adheres to the FAIR principles and integrates seamlessly with FHIR-based standards, enabling more effective data exchange and utilization in operational contexts.

Period of Performance:

The government anticipates an Indefinite Delivery Indefinite Quantity contract with an ordering period of two years.

Place of Performance:

The primary place of performance shall be at the government facility located at Building T44 located at Service Road West, Bethesda, MD 20901. Contractor may work remotely or onsite if approved by CARD Director. Space at Building T44 located at Service Road West, Bethesda, MD 20901 will be prioritized for bioinformatics support and deprioritized for computer science and data science staff.

Type of Contract Contemplated:

The government anticipates issuing firm fixed price task orders.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor shall provide scientific data analysis support services in relation to Alzheimer’s disease and related dementias as follows:

In this task category, contractor shall work closely with the NIA scientific staff. Whenever possible, the contractor shall work closely with the scientific team to collaborate, understand the wet lab practices and quality control metrics that are necessary for high quality data output. The contractor shall work closely with the scientific staff to interpret the biological meaning of the data in order to create the best tables, tools, and visualizations to identify and highlight data outcomes.

· Analyze molecular biology and genomic data. including genome-wide genotype data, CRISPR studies, whole genome/exome sequencing, and transcriptomic sequencing, using standard biostatistics/bioinformatics packages as well as machine and deep learning methods

· Collaborate with NIH scientists and other NIH collaborators to perform multi-national analytics and data management efforts related to the genomics of neurodegenerative diseases within a meta-analysis and “big data” framework.

· Lead studies analyzing biobank scale datasets in neurodegenerative disease

· Conduct formal systemic reviews in collaboration with other NIH ICs and external teams in the neurodegenerative disease space

· Prepare manuscripts related to analyses performed in relation to this requirement

In this task category, the contractor shall collaborate with the scientific staff at CARD to prioritize datasets for analysis and data interpretation. The teams will work together to create standardized, best practices for data analysis.

· Analyze molecular genetics and genomic data, including genome-wide genotype data, CRISPR screens, transcriptomics, single cell and spatial technologies, short and long read sequencing using standard biostatistics/bioinformatics packages as well as machine and deep learning methods.

· Develop, implement, and maintain cloud-based analytic pipelines for generating and analyzing multi-modal datasets

· Develop safe applications in the AI space to accelerate the research process in the area of neurodegenerative disease.

In this task category, the contractor shall work with the scientific staff to identify the limits of current tools and where new tool development could provide better insights to disease mechanisms, biomarkers, or therapeutic targets. New assays are constantly being developed and new questions about what the new datatypes can reveal are being considered. The most useful prioritization of resources and skill sets would require the scientific staff and the contractor working closely on how to develop better tools and applications that overcome current limitations.

· Some tools have limits that do not allow CARD researchers to ask important questions. The contractor, when they are able, should work with researchers to develop better tools for data analysis. It is important to establish together, what current limitations are most important to prioritize.

In this task category, the contractor shall help build the data infrastructure to ensure that datasets are properly managed, documented, and available for efficient reuse. Work closely with data stewards and researchers to improve data findability, accessibility, and interoperability. Work with clinicians and researchers to ensure data standards align with clinical needs, regulatory compliance and research objectives. Stay up to date with the latest advancements in FAIR, FHIR data standards.

· Analyze molecular genetics and genomic data, including genome-wide genotype data, CRISPR screens, short and long read whole genome and transcriptomic sequencing, using standard biostatistics/bioinformatics packages as well as machine and deep learning methods.

· Develop, implement, and maintain cloud-based analytic pipelines for generating and analyzing multi-modal datasets.

· Collaborate with NIH scientists and other NIH collaborators to perform multi-national analytics and data management efforts related to the genomics of neurodegenerative diseases within a meta-analysis and “big data” framework.

· Build and maintain safe AI infrastructure for data harmonization supporting FHIR and FAIR data.

· Build and maintain collaborative knowledge transfer utilities in the cloud for public consumption of research deliverables.

LEVEL OF EFFORT

The estimated level of effort per year to perform all requirements under this statement of work is one half (0.5) supervisory analyst, five (5) senior analysts, nine (9) mid-level analysts, nine (9) early-level analysts and three (3) junior analysts (B), and one (1) junior analyst (A), contractor employees for 1,500 hours per year each, or approximately thirty (30) hours per week each. Level of effort is in line with current CARD program goals and may grow or be modified by the federal leadership of CARD as the overall program evolves with time as determined by the Lead Scientist and/or Director of CARD within the IDIQ’s value ceiling.

GOVERNMENT RESPONSIBILITIES

The Government will provide data for analysis, computing resources, and office space to the contractor personnel working under this effort. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party. FAR Clause 52.245-1 Government Property shall be applicable to this requirement.

OTHER CONSIDERATIONS

Travel:

The contractor may be required to travel within the contiguous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel.

All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced. Contracting Officer approved and Contracting Officer’s Representative-authorized travel shall not exceed $99,000 annually.

Please note that time spent travelling may not be billed to the Government. Please see the Federal Travel Regulation for allowable travel expenses, such as fares, rental fees, mileage payments, and other expenses related to transportation per FTR §301-10.2.

Key Personnel:

The Contractor employees providing services for this effort shall be considered key personnel. Personnel requirements are as follows:

Supervisory Scientific Data Analyst

· A PhD in a data science discipline.

· At least 10 years of experience providing genome-related scientific data analytics and data management support services.

· At least one hundred (100) peer reviewed publications and an H index of 100 or more as estimated on Google Scholar focused on statistical analyses in the neurogenetics field.

Senior Scientific Data Analyst

· A PhD in a data science discipline or MD with MPH with at least 1 year of work experience in the field or MS with at least 7 years applied experience.

· At least 5 years of experience in some combination of public health research, data science, applied artificial intelligence, project/data management or software development.

· At least twenty-five (25) publications and/or preprints focused on statistical analysis in neurogenetics and data science fields.

Mid-level Scientific Data Analyst

· A MS or PhD in a data science discipline.

· At least 2 years of experience in combination of public health research, data science, applied artificial intelligence, project/data management or software development.

· Experience consistently leading a team of individuals for projects in public health research data science, applied artificial intelligence, project/data management, or software development.

· At least ten (10) publications and/or preprints focused on statistical analysis in neurogenetics and data science fields.

Early Scientific Data Analyst

· A MS in a data science discipline or equivalent work experience.

· At least 2 years of experience in combination of public health research, data science, applied artificial intelligence, project/data management or software development.

· Experience leading projects in public health research, data science, applied artificial intelligence, project/data management, or software development. At least five (5) publications and/or preprints focused on statistical analysis in neurogenetics and data science fields.

Junior Scientific Data Analyst (B)

· Bachelor’s degree with work experience in data science or recent PhD or MS with no work experience.

· Programming competencies in bash, Python and R. Basic knowledge of statistics.

Junior Scientific Data Analyst (A)

· Bachelor’s degree with no work experience in data science.

· Programming competencies in bash, Python and R.

· Basic knowledge of statistics.

The Contractor shall also identify Key Personnel that will be assigned to this contract, and those personnel shall become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract will be considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Reporting Requirements:

The Contractor shall provide written monthly reports to the Contracting Officer’s Representative (COR) and the Lead Scientist or Director of CARD which summarize all efforts performed during the reporting period. Reports shall be given on the first business day of each month, following the first month of award. All reports shall also include a brief conference call or meeting with the COR and the Lead Scientist or Director of CARD and/or representative project managers to discuss plans for the following month.

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” shall be incorporated into any resulting award by reference.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements:

It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Non-Personal Service Statement

Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).