Full-Time
Senior Biostatistician
Updated on 9/3/2026
CICONIX
11-50 employees
Integrated consulting and biomedical research support
No salary listed
No H1B Sponsorship
Frederick, MD, USA
In Person
US Citizenship Required
 Biology & Biotech (1) |
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- U.S. citizenship is required.
- A successful background investigation is required.
- Ability to obtain and maintain a government security clearance is required.
- Willingness to comply with government vaccination requirements is required.
- Provide clinical data management support according to applicable Food and Drug Administration regulations, guidance, and industry standards, including performing clinical data management activities or providing clinical data management oversight and support.
- Provide biostatistical support and deliverables that meet applicable regulations, guidance, and clinical and nonclinical industry standards, including performing biostatistical support or providing statistical oversight activities.
- Develop a Data Management Plan describing data management activities, processes, and implementation during pre-study conduct, study conduct, and study closure in accordance with Good Data Management Practices, Good Clinical Data Management Practices, Good Clinical Practices, and International Council for Harmonisation guidelines.
- Develop Case Report Forms that accurately and completely capture data required by the clinical protocol, meet Food and Drug Administration submission requirements, and conform to Clinical Data Interchange Standards Consortium, Clinical Data Acquisition Standard Harmonization, and Study Data Tabulation Model controlled terminology standards.
- Prepare, update, and maintain all versions of statistical analysis plans.
- Prepare, update, and maintain all versions of Statistical Programming Validation Plans and statistical programming validation reports, and develop and provide statistical program formats used in statistical programs.
- Prepare, update, and maintain all versions of randomization plans, including randomization lists and keys, and prepare statistical programs used to create randomization lists and keys.
- Develop statistical programming specifications for clinical data and other statistical programs used to produce study tables, listings, and figures for the Data Monitoring Committee, safety surveillance plans, Food and Drug Administration annual reports, interim analyses when applicable, and ad hoc analyses.
- Produce data-populated tables, listings, and figures for studies, the Data Monitoring Committee, safety surveillance plans, Food and Drug Administration annual reports, interim analyses when applicable, and ad hoc analyses.
- Develop and revise statistical programming specifications used to create Clinical Data Interchange Standards Consortium-compliant datasets, Study Data Tabulation Model datasets, Analysis Data Model datasets, and Standard for Exchange of Nonclinical Data datasets.
- Develop define.xml and define.pdf files containing coding conventions used in statistical programs for Clinical Data Interchange Standards Consortium datasets.
- Develop Standard for Exchange of Nonclinical Data datasets conforming to Clinical Data Interchange Standards Consortium standards for nonclinical data.
- Develop Study Data Tabulation Model datasets conforming to Clinical Data Interchange Standards Consortium standards.
- Develop Analysis Data Model datasets conforming to Clinical Data Interchange Standards Consortium standards as required.
- Develop and update Clinical Data Interchange Standards Consortium Reviewer's Guides.
- Provide written responses to sponsor and Food and Drug Administration requests and queries regarding statistical products.
CICONIX provides an integrated suite of consulting and diagnostic support services for health and human services challenges, with a particular focus on program development and biomedical research assistance to advance healthcare for America's Warfighter community. Its offerings combine advisory services and diagnostic support to help clients design and implement programs, guide biomedical research efforts, and identify opportunities to improve operations across their business lines. The company differentiates itself through its end-to-end, integrated approach and its specialization in military healthcare needs, along with a commitment to maintaining a strong work-life balance for its employees. CICONIX aims to help clients capitalize on opportunities for enhanced operational success while delivering a supportive workplace for its staff.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Annapolis, Maryland
Founded
2012
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Simplify's Take
What believers are saying
- CICONIX won a $4.08 million NICoE task in July 2026.
- FY2026 already shows nine award actions and $333,292 net obligations.
- Federal award history totals $55.2 million across 25 awards, proving repeat demand.
What critics are saying
- CICONIX depends heavily on DoD and DHA; losing recompetes hits revenue fast.
- The 2026 STARS III option ends July 1, 2026, forcing renewal pressure.
- Employee reviews in 2026 cite hostile management, weak job security, and cut-and-run behavior.
What makes CICONIX unique
- CICONIX specializes in warfighter healthcare, clinical research, and federal health support contracts.
- It holds OASIS+, SeaPort NxG, and GSA STARS III vehicles.
- Its integrated consulting and diagnostics model fits defense health clients' administrative needs.
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Benefits
Health Insurance
Paid Vacation
Relocation Assistance