LMI

  • Regulatory Biostatistician

    Job Locations US-MD-Fredrick
    Posted Date 1 month ago(6/12/2019 2:29 PM)
    Job ID
    2019-3458
    # of Openings
    1
    Category
    Project Management
  • Overview

    We are seeking a Regulatory Biostatistician to assist in organization, planning, assessment and management of regulatory affairs (i.e., FDA) and quality assurance activities. ideal candidate will have experience providing statistical expertise to biotechnology, pharmaceutical drug and/or medical device products. This position supports The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) is the US Department of Defense (DoD) point for research, development, acquisition, fielding and life-cycle support of biological, chemical and nuclear defense equipment and medical countermeasures to the Army, Navy, Air Force, Marine Corps, and Special Operations.

     

    As a not-for-profit company, we deliver the best value for the government dollar, as all revenues are directed to our mission of advancing government rather than to delivering shareholder value. We operate completely free of political and commercial bias, and we are entirely aligned with the goals of our clients. Our clients value our independence as well as our extensive domain knowledge in logistics, intelligence, homeland security, health care, and energy and environment markets. We believe government can make a difference, and we seek talented, hardworking people who share that conviction.

    Responsibilities

    • Provide expert analysis and advice on the development, management, and improvement of a regulatory organization.
    • Define and document regulatory strategy; provide analysis of candidate maturity; and draft, review, and approve requisite target product profiles of candidates considered promising for advanced development.
    • Advise on, review, and evaluate the presentation of data standards in accordance with current regulatory guidance.
    • Provide statistical training for non-statistical groups.
    • 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.
    • 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.
    • 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.
    • Develop Statistical Analysis Plans (SAPs) for studies to support approval of new drugs, biologics, and/or medical devices.
    • 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.).
    • Provide statistical oversight of ongoing clinical and non-clinical studies and manufacturing development (e.g., process validation, sample sizes, stability studies, etc.).
    • Develop innovative statistical methods for non-clinical and clinical study protocols to support investigational and marketing applications.
    • 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.).
    • Provide expert analysis and advice on the development, management, and improvement of a regulatory organization.
    • Define and document regulatory strategy; provide analysis of candidate maturity; and draft, review, and approve requisite target product profiles of candidates considered promising for advanced development.
    • Implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities. 
    • Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts.
    • Participate as a regulatory point of contact during product development efforts in order to facilitate cross-communication. In addition, present, orally and in writing, the outcome of these efforts in a timely manner.
    • Determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels.
    • Participate in medical systems acquisition management activities (e.g., IPT meetings, reviewing acquisition documentation, etc.) and present the outcome, orally and in writing, in a timely manner.
    • Travel for presentations and seminars, and conduct and provide oversight of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.). This will include the following:
      • Inspection of contract laboratories or other facilities, providing data in support of GLP studies to assure compliance with GLP guidelines, applicable protocols, and SOPs
      • Periodic facility audits of facilities, equipment, and records required by GLPs
      • QMS audits of ISO/FDA elements related to the control of documents and data
      • Regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
      • GCP training and the development and maintenance of GCP-related quality systems
      • GCP compliance audits of investigator sites, CRO facilities, and vendors, including clinical sample labs in accordance with audit plans
      • Internal and external current GMP audits in support of the supplier evaluation program to identify and evaluate all risks

    In addition, shall provide expert analysis and advice in the follow-up actions (e.g., formal reports, updates of related databases, etc.) of these audits and inspections.

    • Assist Headquarters elements in their understanding of the scientific complexity of the research and development efforts and compliance with regulatory and quality regulations surrounding those efforts.
    • Analyze any regulatory issues, providing corresponding risk assessments and guidance on developmental paths forward and presenting/defending these analyses orally and in writing.
    • Apply regulatory analyses based on FDA regulations, regulatory policies, and DoD regulations and guidance across the JPEO-CBD Medical portfolio and present findings, orally and writing.
    • Assess the JPEO-CBD Medical portfolio for sound science and regulatory compliance with FDA regulations and provide assessment and analysis of associated risks, orally and in writing, in a timely manner.
    • Format regulatory submission in the eCTD format.
    • Assist the Risk Manager in risk identification and analysis, as well as development of mitigation plans.
    • Plan (i.e., develop meeting agendas), participate in, and provide support (i.e., develop meeting minutes and track action items) to the RA/QA working group.
    • Review and assess JPEO-CBD Medical portfolio documents and relevant medical science and technology program documents to assure alignment to advance development efforts (e.g., being able to develop a new drug under FDA rules, and be an advocate for drug development based on FDA rules/regulations, etc.).
    • Attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner.
    • 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.
    • 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.

    Qualifications

    • Current Secret Clearance or ability to obtain
    • Master’s degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
    • Alternate/Tradeoff Requirement:  Bachelor’s degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
    • Mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) Medical portfolio.
    • Possess experience in complying with statistical aspects implied in the Animal Rule, assay, manufacturing validation, and/or stability studies.
    • One (1) year of experience providing input to FDA submissions and/or developing statistical plans supporting non-clinical and clinical plans.
    • Expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge to the development of a regulatory/quality organization conducting non-clinical and clinical studies and manufacturing development efforts. In addition, be capable of applying this expert knowledge to complex technical problems with minimal supervision. 
    • Knowledge of GLP.
    • Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.
    • Experience providing statistical expertise in early and/or advanced development of biotechnology, pharmaceutical drug, and/or medical device products.
    • Experience working in a regulated industry environment (GMP, GCP, and/or GLP), as well as an understanding of FDA regulations and ICH guidance.
    • Desired: regulatory affairs certification.

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