Job Location: Frederick MD
We are seeking a Biostatistician for an anticipated procurement to provide research support services to the MRDC Office of Regulated Activities. Availability of this position is contingent upon contract award.
Odyssey Systems Consulting Group, Ltd. is committed to providing world-class technical, management, and scientific support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized for driving projects from the planning stages, through implementation, and into operations and support.
Duties include, but not limited to:
- Provide biostatistical support for sponsored clinical and non-clinical trials on behalf of MRDC and other DoD organizations, ensuring compliance with all statistical regulatory requirements as defined by the Food and Drug Administration (FDA), as well as Good Laboratory Practice (GLP) regulation, Good Clinical Practice (GCP) regulation, and relevant sections of other FDA regulations, i.e. 21CFR and 11CFR.
- Develop statistical models using clinical and biological data that will inform clinical trial design (e.g. statistical methodology, study design, sample size calculations, screening, randomization, inclusion/exclusion criteria, etc.)
- Adhere to biostatistical Standard Operating Procedures (SOPs) and internal procedures, FDA Guidance, International Council for Harmonisation (ICH) documents, and if applicable the external regulatory sponsor’s SOPs.
- Attend the IPT and working group meetings (either on-site or via telcon_.
- Provide advice and consultation support to the IPT and working groups and communicate with the Chief of Biostatistics in regard to key issues that arise.
- Assist with the development of position papers, statistical analysis plans, mock tables, listings and figures, interim analysis plans, statistical programming validations plans, technical issues associated with reports, technical issues associated with data analysis, and technical issues associated with the FDA data deliverables.
- Assist medical writers (or the external regulatory sponsor’s medical writers) with statistical issues associated with the preparation of the Clinical Study Report and other documents to be submitted to the FDA.
- Assist with the statistical analyses for the FDA Annual Report and assist medical writers with statistical issues associated with FDA communications and FDA briefing documents, as needed.
- Attend FDA meetings and conference calls, as needed.
- Bachelor's or Master's degree in Bioinformatics, Computer Science or related scientific discipline with five (5) years of relevant experience in analyzing human datasets, with the ability to analyze and interpret data.
- Computer skills to include Microsoft Office Suite.
- Experience with SAS, SPSS and other statistical software packages, and knowledge of mathematical and statistical theory and its application to many scientific fields.
- Candidates with a solid understanding of theoretical background including statistics used in bioinformatics analysis will be preferred.
- Ph.D. in Bioinformatics, Computer Science or related scientific discipline with three (3) years of relevant experience is preferred
- Existing SECRET clearance is desired
- Place of Performance: Frederick MD and/or offsite
- Secret Eligibility
- US Citizenship
- Travel may be required
Odyssey Systems Consulting Group, LTD. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, national origin, disability, sexual orientation, gender identity or expression, marital status, genetic information, protected veteran status, or other factors protected by federal, state, and/or local law. This policy applies to all terms and conditions of employment.
- Military Leave
- On Site Cafeteria
- Vacation/paid time off
- Employee Events
- Gym Memberships
- Professional Development
- Life Insurance
- Employee Referral Program
- Medical, Dental and Vision
- Paid Holidays
- Tuition Reimbursement
- Flexible Spending Accounts
- Paid sick days
- Maternity/Paternity Paid Leave
- Retirement / Pension Plans