Clinical Research Management, Inc. (CRM) is a government contractor specializing in
infectious disease research in the US and abroad. CRM provides GxP services, research
personnel, and support services, contributing to the development of vaccines, drugs, and
devices, to help prevent, diagnose, and treat human disease. CRM has immediate need for a
Biostatistician in Frederick, MD.
Responsiblities include, but are not limited to:
1. Establish an infrastructure for the discipline of Biostatistics and Statistical Programming
for FDA regulated clinical studies in human subjects.
a. Develop Biostatistics Standing Operating Procedures (SOPs), templates and forms, e.g.,
including, but not limited to: Statistical Analysis Plan SOP and template, Randomization SOP,
Unblinding SOP, standard tables, listings and graphs templates, etc.
b. Develop Statistical Programming SOPs, templates and forms, e.g., including but not limited
to: Statistical Programming Plan SOP and template; Development of Tables, Listings & Graphs
SOP; Validation of SAS Tables, Listings & Graphs SOP; standard tables, listings and graphs
c. Author and/or contribute to writing the statistical methods section of clinical protocols.
d. Review and comment upon protocols prepared for FDA regulated clinical studies in human
subjects by Principal Investigators and/or partners as requested.
e. Review study-specific procedures and documents (e.g., Statistical Analysis Plans,
randomization procedures, unblinding procedures, Statistical Programming Plans and tables,
listing and graphs for FDA regulated clinical studies in human subjects) as requested that are
prepared and submitted by contractors and/or clinical study personnel.
f. Participate in education and training on clinical Biostatistics and Statistical Programming
SOPs, templates and forms.
g. Effectively communicates simple and complex statistical solutions for statistical analysis
issues with contractors and/or partners.
h. Effectively interpret analyses and write statistics reports as requested.
i. Assists in developing documents and mechanisms for managing CROs or contractors used for
statistical work, e.g., monitoring progress, intervention and problem solving, etc.
REQUIRED SKILLS / EXPERIENCE
Candidates must have the following attributes:
1. Masters or PhD qualified in statistics, biostatistics, quantitative biology or a similar
discipline is required.
2. Training in the biological and clinical sciences is required.
3. Demonstrated experience in biostatistics and statistical programming for FDA regulated
clinical studies in human subjects.
4. 5+ years experience in Biostatistics and statistical programming for FDA regulated clinical
studies in human subjects.
5. 5+ years industry experience with SAS and/or other statistical programming software.
6. Knowledge of FDA regulations and ICH standards for design, conduct and analysis of clinical
trials is required.
7. Experience in creating designs of experiments, performing sample size calculations, writing
and implementing statistical analysis plans, writing statistical sections of protocols and
final study reports and forecasting contingencies related to design and outcomes.
8. Knowledge of 21 CFR Part 11 and use of validated systems and associated processes.
9. Experience managing activities of contract research organizations for statistical services.
10. Experience with MS Office software, including Outlook, Word, Excel, PowerPoint, MS
Project, Visio and SAS is preferred as well as a conceptual knowledge of clinical database
11. Demonstrates excellent written, verbal, inter-personal and communication skills and
excellent organizational skills.
12. Candidates must be US Citizens or Permanent Residents.
CRM currently offers the following benefits to full-time employees:
3 weeks paid vacation, paid leave on federal holidays, paid sick leave
Annual budget for tuition assistance, continuing education, seminars, etc.
Long Term Disability Insurance
401(k) retirement plan with company matching
Medical and Dependent Care Flexible Spending Accounts
Qualified candidates will receive consideration for employment without regard to race, color,
religion, sex, or national origin. Candidates for positions under CRMs contracts with the
Department of Defense (DOD) will be required to pass one or more background/security
investigations conducted by the DOD, U.S. Army or other federal government agency. Such
investigations may include criminal records and credit history checks.
CRM is an EOE.
* Please submit only 1 resume per position. Contact will only be made if there is further
interest, based on qualifications.
* All posted opportunities are full-time position, unless otherwise stated.