Scientist V

Overview

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

Summary:

The Scientist V shall assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities.

Responsibilities

Essential Job Functions:

• The contractor shall provide statistical oversight of ongoing clinical and non-clinical studies and manufacturing development (e.g., process validation, sample sizes, stability studies, etc.).
• The contractor shall develop innovative statistical methods for non-clinical and clinical study protocols to support investigational and marketing applications.
• The contractor shall propose, develop, evaluate, and verify statistical methodologies performed to support non-clinical and clinical projects (e.g., study designs, sample size calculations, data quality, randomization, etc.).
• The contractor shall propose, develop, evaluate, and verify statistical methodologies performed to qualify and validate assays, manufacturing processes, and stability studies.
• The contractor shall review study reports, published literature, and project documents as needed to develop white papers and position papers to support historical perspectives or present and support innovative statistical methodologies.
• The contractor shall provide statistical training for non-statistical groups.
• The contractor shall educate and advise non-statisticians (e.g., project management, clinicians, scientists, etc.) on statistical methodologies and approaches, analytical issues to findings, and the process to identify and discuss risks.
• The contractor shall participate as the statistical subject matter expert during IPT meetings, providing guidance to scientific and non-scientific personnel on the planning of clinical and non-clinical studies.
• The contractor shall participate as the statistical subject matter expert during official and unofficial meetings with regulatory agencies (e.g., FDA, etc.) and be capable of defending the proposed statistical plan.
• The contractor shall develop Statistical Analysis Plans (SAPs) for studies to support approval of new drugs, biologics, and/or medical devices. The contractor shall analyze data and study reports and provide statistical interpretations for regulatory submissions (e.g., integrated summary of safety and integrated summary of efficacy submissions, etc.).

Qualifications

Necessary Skills and Knowledge:

• Shall have 5+ years of working experience with Microsoft Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word.
• The contractor shall possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
• The contractor shall possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other government and contractor experts.

Minimum Qualifications:

• Shall possess a Doctorate degree in Chemical Engineering, Statistics, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: Master's degree in Chemistry, Organic Chemistry, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
• Shall possess senior level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
• Minimum 5 years of hands-on manufacturing experience in the private sector.
• Clearance: Secret

Preferred Qualifications:

• 10+ years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval)
• Preferred, but not required: The contractor shall have experience aligning FDA processes with DoD acquisition requirements for the development and procurement of medical products and systems for biodefense.

Pay and Benefits

The salary range for this position is $170,000 to $250,000 annually.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.