Senior Biostatistician

CICONIX, LLC•Fort Detrick, MD

2d•Onsite

About The Position

CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact. CICONIX is seeking a Senior Biostatistician to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. The role involves providing clinical data management support according to the applicable FDA regulations, guidance, and industry standards. Data management support includes performing clinical data management activities or providing clinical data management oversight, support responsibilities. The position also provides biostatistical support and deliverables that meet the applicable regulations, guidance, and standards, including industry standards (clinical and nonclinical). Biostatistical support includes performing biostatistical support or providing statistical oversight activities.

Requirements

TBD
U.S. Citizenship and a successful background investigation are required.
Ability to obtain and maintain a government security clearance.
Willingness to comply with the government vaccination requirements.
Education: TBD
Licensure & Certifications (Current & Unrestricted): TBD
Experience: TBD

Responsibilities

Develop a Data Management Plan (Deliverable 17), which is a comprehensive document developed to describe all data management activities and their processes and implementation during pre-study conduct, study conduct, and study closure and that reflect Good Data Management Practices based on Good Clinical Data Management Practices (GCDMP), Good Clinical Practices, and ICH guidelines.
Develop Case Report Forms (CRFs), which are a series of questionnaire forms used as a data collection instrument for accurately and completely capturing the data required by the clinical protocol, that meet the FDA submission requirements and conform to Clinical Data Interchange Standards Consortium (CDISC)/ Clinical Data Acquisition Standard Harmonization (CDASH) standards and Study Data Tabulation Model (SDTM) controlled terminology.
Prepare, update, and maintain all versions of statistical analysis plans.
Prepare, update, and maintain all versions of Statistical Programming Validation Plans, and all versions of statistical programming validation reports; Develop and provide statistical program formats used in the statistical programs (all versions).
Prepare, update, and maintain all versions of randomization plans including randomization list(s) and key(s), prepare statistical programs used to create randomization list(s) and key(s).
Develop statistical programming specifications (clinical data) and other statistical programs used to produce the tables, listings, and figures for studies, all versions used for the Data Monitoring Committee, safety surveillance plans, FDA annual report, interim analyses (if applicable), and any ad hoc analyses.
Produce data-populated tables, listing, and figures for studies, the Data Monitoring Committee, safety surveillance plans, FDA annual reports, interim analyses (if applicable), and any ad hoc analyses.
Develop and revise as required statistical programming specifications used to create CDISC-compliant datasets, SDTM, Analysis Data Model datasets, and Standard for Exchange of Nonclinical Data (SEND) (for non-clinical data); Develop define.xml and define.pdf to include coding conventions used in the statistical programs (all versions) for CDISC datasets; Develop SEND datasets conforming to CDISC standards (non-clinical data); Develop SDTM datasets conforming to CDISC standards; Develop Analysis Data Model datasets conforming to CDISC standards as required.
Develop and update as required by CDISC Reviewer’s Guides.
Provide written responses to sponsor and FDA requests/queries regarding statistical products.