RFI_Edits_16_Jul_18.docx

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RFI for Biostatisticians
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W81XWH18R0086
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This Request for Information (RFI)/Sources Sought (SS) Notice is for market research, information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of Walter Reed Army Institute of Research (WRAIR) or the US Army Medical Research Acquisition Activity (USAMRAA).

This market research is seeking Women Owned Small Business sources only that have the knowledge and capabilities to provide Biostatics Services. The NAICS Code for this requirement is 541715. Only capability statements and/or fact sheets information from Women Owned Small Businesses will be accepted. The objective of this requirement is for biostatistician services at various level (Biostatistician I, Biostatistician II and Biostatistician III) on an as-needed basis for WRAIR to support various research projects. The Contractor shall provide:

•Interpretation of results
•Manuscript and grant preparation
•Statistical aspects of study design
•Choosing statistical methods
•Multivariable modeling
•Other statistical analyses
•Sample size planning
•General biological data mining
•Statistical analysis for results reporting
•Database consultation and generation

Examples of work include Generalized Estimating Equation (GEE) models for repeated measures analyses accounting for hierarchical data (and sample size calculation for such a study post-estimation regression model diagnostics -handle approaches to confounder & mediator identification and causal inference -machine learning approaches (e.g. COP discovery from large scale data mining, comparing the genomic sequence of a pathogen to the transcriptional response it elicits in the host following infection). This would possibly include some small degree of host/pathogen interaction modeling, and might benefit from some experience in machine learning familiarity with large data sets, especially transcriptional and sequence studies, to conduct PCA and tSNE analyses and the ability to tweak model parameters to do things like account for confounding variables, atypical distributions, Also, the ability to examine the interrelatedness of larger data sets beyond the level of a simple Pearson/Spearman correlation or linear regression; this would allow WRAIR to identify truly novel correlates and driving factors within the experiments.

Specific Tasks include:

Biostatistician Research Services:

The Contractor shall assist in the conduct of clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP). All of the work for this research must be performed in accordance with the Federal, DoD, and Command laws, regulations, and policies. Clinical research studies require production of experimental products, conduct of research studies, laboratory analysis of samples, analysis of resulting data, and submission of study findings. The Contractor shall:

1.1.Provide statistics and biostatistics leadership for clinical trials.
1.2.Provide technical assistance to the staff, including assisting staff with design or analysis tasks and/or jointly meeting with clients seeking statistical and computing services.
1.3.Assist in the development of the statistical portion of human protocols. Calculate the appropriate number of subjects needed for varying levels of statistical power. Make recommendations on statistical power calculations to investigators.
1.4.Provide expert consultation in the development of a statistical analysis plan (SAP) to meet the objectives of the protocol.
1.5.Provide clear oral and written advice in English with regard to statistical procedures.
1.6.Provide clearly written technical edits that improve statistical aspects of documents, such as research protocols or manuscripts.
1.7.Draft clearly written data, statistical design, sample size, and analysis sections for documents such as research protocols or manuscripts from clients.
1.8.Co-author scientific/technical manuscripts.
1.9.Assist in the development, analysis, or review of formal protocols subject to national and international regulations.
1.10.Document critical reviews at an appropriate level for the intended audience. Reviews are conducted for manuscripts and publications written by others with regard to good statistical practices.
1.11.Produce products free of obvious errors and consistent with statistical methods published in peer reviewed literatures. In all cases, reports, statistical algorithms, computer programs and data used to generate results shall be provided in digital formats.
1.12.In General, Call Orders may consist of, but are not limited to:
•Sample size estimation, calculations of effect size and power, & written justifications of same for use in IACUC protocols (as well as signing approval of IACUC protocol)
3-5 per Order
•Consultation and open communication regarding experimental design and data analysis considerations and statistical interpretations
oUp to 20 consultations of various degrees of consultation.
•Stochastic and deterministic epidemiological and clinical models.
oUp to 3-5 per Order
•Test for differences among groups, or relative to a control/mock/placebo group, using parametric and non-parametric analyses
oUp to 20 study or project based with multiple data
•Correlations, regressions, and other relatedness assessments of various data in pursuit of biomarkers, correlates, etc., including PCA and tSNE\
oUp to 10 per Order
•Assistance with / production of publication-ready graphical representation of data, particularly in the case of PCA, tSNE, heat map, and other similarly cumbersome data sets
oUp to 10 per Order
•Analysis of significance among extremely large data sets, i.e., RNAseq, including necessary corrections, transformations, and post-hoc analyses
oUp to 5 per Order

1.13. The Contractor shall provide the appropriate level biostatistician support personnel within 10 business days of receipt of the Governments order.

The contractor and staff experience in conducting Biostatistics should include statistical studies to generate data and insights used to innovate, plan and support improved healthcare outcomes and processes. Prepares analysis plans to ensure the best statistical methods are developed and utilized. Writes specifications for files, consistency checks, tables, and calculations used to collect and analyzes data from a variety of sources. Interprets analyses and prepares exhibits for reports and presentations. Interfaces with non-technical users to assist with data interpretation and understanding of results. Proficient with statistical computer applications like SAS and R.

The estimated period of performance would be September 30, 2018 – September 29, 2023, No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Availability of any formal solicitation will be announced under a separate announcement. This synopsis is for market research, information and planning purposes only and is not to be construed as a commitment by the Government. Each response must reference the sources sought title. All proprietary information should be marked as such. Responses will be held confidential if requested. Please submit fact sheets/capability statements to the attention of USAMRAA, Attn: Ashley Atkins, 820 Chandler St. Ft. Detrick, MD 21702. Fact sheets/Capability Statements must be emailed to: Ashley.n.atkins.civ@mail.mil. Responses must be received no later than 23 July 2018.

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