D. Attachment 1 - Statement of Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Biostatistics Consulting Services

Statement of Need and Purpose:

The Clinical Trials Unit (CTU) provides support to the NINDS intramural research program from study start to study completion. The Biostatistics Office and the support provided by the CTU biostatisticians is both consultative and collaborative in nature.

The Contractor fulfilling the position of this request, provides the following Biostatistics Services:

• Expert and strategic biostatistical technical support, guidance, education, and advice on advancing Government projects through nonclinical and clinical development.

• Preparation and review of statistical analysis plans, providing detailed specifications for analysis files, consistency checks, tables and figures; communicates with Government staff and investigators regarding statistical protocol design and data analysis issues.

• Evaluation of the design of Government proposed studies and milestones for sound statistical analysis methodology to ensure studies are sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the results.

• Interpretation and, as needed, performance of interim and final analyses and assistance in the writing of statistical sections of study reports and manuscripts.

• Descriptions and explanations of statistics in plain language and participation in educational activities when requested.

• Providing feedback and recommendations of a biostatistics nature on projects through written documents, conference calls, and by email. Provide technical review and feedback of a biostatistics nature regarding project milestones, progress reports, development plans, study design, and data interpretation.

• Interacting with Federal staff and clinical trial investigators to facilitate discussions in support of Government research strategy with regards to statistical methods for clinical trials as the Government prepares a written protocol

Background Information and Objective:

The National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) staff work with investigators at the NINDS Division of Intramural Research (DIR) in specific neurological and clinical research areas, including protocol development of interventional and non-interventional clinical research studies for neurological disorders and stroke. In addition to advising intramural investigators in the conception, development, implementation, and execution of clinical research studies and clinical trials, CTU interacts with the extramural Offices of Translational Research (OTR) and Clinical Research (OCR) to support the mission of NINDS.

The CTU provides expertise to NINDS investigators in the conception, design, implementation, execution, analysis, and reporting of clinical research. CTU staff advise the investigators and the Institute on clinical research methodology, research ethics, safety monitoring, clinical research data sharing, clinical trial reporting, and gender and minority tracking.

The Biostatistics office of the CTU, provides high level statistical expertise advising study teams in study design and statistical methods during the protocol development and protocol review phase and performs interim and final analyses, as requested.

The research conducted in the DIR, demands advanced statistical solutions and knowledge of state of the art study design to provide the DIR investigators with the most advanced techniques available.

Period of Performance:

The period of performance shall be a one-year base period plus two (2) one-year option periods as follows:

Base Period: January 1, 2025 – December 31, 2025 – Qty 20 hours Option Line 2 – Qty NTE 80 hours Option Line 3 – Travel NTE $1,200.00

Option Year 1: January 1, 2026 – December 31, 2026 – Qty 20 hours Option Line 4 – Qty NTE 80 hours Option Line 5 – Travel NTE $1,200.00

Option Period 2: January 1, 2027 – December 31, 2027 – Qty 20 hours Option Line 6 – Qty NTE 80 hours Option Line 7 – Travel NTE $1,200.00

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:

Provide expert and strategic biostatistical technical support, guidance, and advice on advancing Government projects through nonclinical and clinical development.

Prepare and review statistical analysis plans, provide detailed specifications for analysis files, consistency checks, tables and figures; communicate with Government staff and investigators regarding statistical design and analysis issues.

Prepare process optimization and validation plans upon request.

Evaluate the design of Government studies and milestones for sound statistical analysis plans to ensure they are sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the studies and results.

Interpret and, as needed, perform analyses and assist in the writing of statistical sections of study reports.

Explain statistics in plain language.

Participate in educational activities for the benefit of DIR staff and trainees; providing investigators with foundational and advanced statistics to help advance their work and the NINDS mission.

Provide feedback and recommendations of a biostatistics nature on projects through written documents, conference calls, and by email. Provide technical review and feedback of a biostatistics nature regarding project milestones, progress reports, development plans, study design, and data interpretation.

Interact with Federal staff and clinical trial investigators to provide scientific information in support of Government research strategy with regards to statistical methods for trials as the Government prepares protocol and grant applications.

Specific Requirements:

The NIH estimates that the level of effort for this requirement shall be one (1) contractor SME on a part time basis.

The required level of effort varies depending on the quantity and complexity of projects at any given time. Accordingly, a minimum and maximum level of effort is anticipated. A minimum of 20 hours and a maximum of 100 hours of support is required annually for the Base Period and all Option Periods. Hours above the annual minimum shall be exercised, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

GOVERNMENT RESPONSIBILITIES

Government furnished property, in the form of a laptop, shall be provided. Project related data will be provided to the contractor for performance of work efforts. All data provided to consultant must be treated as confidential and not be disclosed to any third party.

Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 80088 (current revision) or if information is still needed contact the COR for approval to store data longer. NINDS requires that the consultant meet certain minimum requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have:

• Virus protection with regular automated scans

• Up to date security patching

• Two factor authentication

• Encryption FIPS 1402 compliant encryption solution

• Regular vulnerability scans and if the scan produces any high or medium results they need to be corrected highs within 30 days and mediums within 90 days

• Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

• Consultant will have to sign the NIH non disclosure agreement http://irtsectraining.nih.gov/NIH_NonDisclosure_Agreement.pdf

• Report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the loss or theft even if the data is on a contractor furnished computer.

• Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

DELIVERY OR DELIVERABLES

The Contractor will complete projects within the timeframe allotted by the Government, dependent on project, but will be given – on average – no less than 15 business days to complete reports. Timely submission of deliverables is essential. Deliverables can be submitted as an electronic copy, unless otherwise demanded by the project. If a hard copy is required, the Contractor will be notified at the beginning of the individual project.

REPORTING REQUIREMENTS

The Contractor is not routinely required to provide written progress reports, but is expected to attend any meetings and meet any deadlines applicable to the individual deliverables assigned. The Contractor is expected to work with the NINDS CTU to coordinate and meet project deadlines.

OTHER CONSIDERATIONS

Travel:

The Contractor may be required to travel within the contiguous United States to provide the services described in this SOW. The Contractor shall make its own travel arrangements; the Government shall reimburse all reasonable travel costs up to the Government approved limits.

All travel arrangements must be made in accordance with Federal Travel Regulations in effect at the time of travel and must be approved by the Contracting Officer’s Representative and authorized by the Contracting Officer prior to being finalized or invoiced.

Key Personnel:

Has a PhD in a biostatistical discipline At least 10 years biostatistical experience in the biotechnology or academic sector At least 5 years demonstrated experience in:

o Design and review of nonclinical animal research plans and/or analysis of nonclinical animal research results for IND-enabling studies or clinical studies o Design of clinical trial protocols, innovative and adaptive designs, review of statistical analysis plans, and validations plans.

o Statistical interpretation of published results or critique of scientific proposals o Statistical support to non-clinical and/or clinical development efforts o Adaptive clinical trials design

At least 5 years of subspecialty biostatistical knowledge in the pediatric and rare-disease adeno-associated vector 9 (AAV9) and pediatric neuromuscular first-in-human clinical trials, with experience on pediatric first-in-human phase 1 and/or phase 1/2 neuromuscular trials designs preferred (such as giant axonal neuropathy or congenital myasthenia)

At least 5 years clinical trials methodology and biostatistics teaching experience

Information System Security Plan:

The statement of work requires the contractor to have the ability to access federal information systems therefore all information security policies attached apply to the contractor awarded under this contract.

Data Rights:

The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs 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,” is hereby incorporated by reference and shall be made a part of any resulting award.

Project related data will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and shall not be disclosed to any third party.

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).

Publications and Publicity:

The Contractor can reasonably be expected to be included on publications relating to their work under this contract at NINDS.

Confidentiality of Information:

Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature.

Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project.

Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer.

Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information.