Clinical Research Management - Silver Spring, MD (30+ days ago)3.2

Job Details
ICON Government and Public Health Solutions (a trade name of Clinical Research Management, Inc.) specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.

This position on a Government-awarded contract to ICON GPHS will provide statistical services to support the design, implementation, analysis, and reporting of research protocols that will include, at a minimum:1) assisting in developing the statistical plan for protocols involving clinical trials of investigational products, including power calculations 2) preparing randomization schemes and tables, listings and figures 3) assisting in CRF review, design, and preparation 4) analyzing data sets and provide results as needed by the study team 5) providing training to staff as needed, and 6) assisting in writing statistical portions of study reports and manuscripts. All statistical services will comply with the protocol procedures, Sponsor requirements, and regulatory standards to support FDA submissions. No variation is acceptable. Costs will be within budget agreed with COR. Internal and external review of statistical products by Investigators, Sponsors, Quality, and Regulatory personnel. COR will review invoices to ensure that costs do not exceed budget by more than 5%. Statistician must have a Ph.D. or M.S. in statistics, and be capable of working in the CDISC format (prior experience with 12-15 CDISC databases). Applicant should be a United States citizen to facilitate the required security clearance. Biostatistician should ideally have experience in statistical analysis for FDA clinical trials for new drugs and investigational products.

Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

Provide statistical collaboration and/or consultation to research scientists, investigators, database designers, and managers of WRAIR/NMRC and outside clients. This includes communicating clearly and effectively in order to understand and clarify the goals of the client, and providing well-reasoned solutions to the problems presented by the client.
Provide technical assistance to the staff, including assisting staff statisticians with design or analysis tasks and/or jointly meeting with clients seeking statistical and computing services.
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 study investigators.
Contractor shall provide expert consultation in the development of a statistical analysis plan (SAP) to meet the objectives of the protocol.
Apply a variety of biostatistical methods and tools. Expected application areas include analysis of variance, survival analysis, logistic regression, generalized linear mixed-effects models and construction of graphical displays for statistical visualization.
Perform SAS programming to meet the needs of clinical trials as defined in the SAP. Contractor will develop data display shells and mock tables, listings and figures to test the system prior to implementation. Contractor shall prepare and present final tables, listings and figures to investigators. Contractor shall maintain records and version control for program.
Provide clear oral and written advice in English with regard to statistical procedures.
Provide hands-on training on how to use statistical software for all or some of the following: SAS, PASS, SPSS or other statistical software packages, if requested by study staff and/or investigators. Web-based sites offering statistical tools for the purposes of design and analysis may be allowed if discussed with study team and offering additional functionality.
Provide clearly written technical edits that improve statistical aspects of documents, such as research protocols or manuscripts from clients of the Department of Translational Medicine.
Draft clearly written data, statistical design, sample size, and analysis sections for documents such as research protocols or manuscripts from clients.
Co-author scientific/technical manuscripts.
Assist in the development, analysis, or review of formal protocols subject to national and international regulations.
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.
With the approval of the COR, the employee may be given time and encouraged to review relevant statistical literature and adapt statistical methods as necessary.
Shall internally document assumptions, data sources, databases, procedures, statistical analyses, and computer programming code so that results can be replicated even if the originating staff member is no longer available. Data sets, analysis software, and documentation shall be in digital format, accessible to the COR, and shall be provided to the COR/audited semi-annually and upon expiration of the contract.
Technical support meetings with the department staff and approved consulting and/or collaborative research with WRAIR/NMRC investigators shall be scheduled consistent with their needs.
Products provided to the customers shall be 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.
Shall provide weekly status reports delivered to the COR and Chief of the Clinical Trials Center by COB on the last day of the week including the following: Topic of the task worked during that week, Name and Division/Directorate of the client, Date the task was requested by the client, Requested products, Type of animal species involved, whether a product was delivered, and the nature of any product delivered (meeting, e-mail, report, ..., etc.). In addition to the status report, additional reports may be requested as deemed necessary by the COR..
Maintains a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Employee is required to complete mandatory training as assigned for contract staff by the Commander, Walter Reed Army Institute of Research, and to comply with other organizational policies of WRAIR that pertain to contract employees.

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required.

The employee must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate.


Masters or better in Statistics or related field.


PhD or better in Statistics or related field.


Ability to perform statistics with databases that are in the FDA required CDISC format.
Masters’ degree or Doctorate in Biostatistics
U.S. Citizenship
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.