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ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management.  We help forward thinking clients solve problems and improve operations. 
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ProSidian Seeks a Senior Statistics SME | Healthcare and Life Sciences [HHS125030] - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Executive Consultant/SME II Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA's mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.

Seeking Senior Statistics SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS.  This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary.

JOB OVERVIEW

Provide services and support as a Healthcare And Life Sciences (Senior Statistics SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services  (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World).

RESPONSIBILITIES AND DUTIES - Senior Statistics SME | Healthcare and Life Sciences [HHS125030]

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers  immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs)
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Provide subject matter expertise in innovative statistical thinking and methods to help drive the enhanced quantitative l MCM development paradigm within BARDA.
• Standardize statistical processes and methodologies across therapeutic areas.
• Provide support to BARDA's development networks guiding and monitoring sponsored research with Contract Research Organizations (CROs).

Desired Qualifications For Senior Statistics SME | Healthcare and Life Sciences [HHS125030] (HHS125030) Candidates:

• Subject Matter Expert (SME) in statistical methods for the development of medical countermeasures against chemical, biological, radiological, and nuclear threats
• 15+ years for Senior Statistician SME.
• Experience applying advanced statistical methods to the development of medical countermeasures (MCMs) in accordance with regulatory standards (GLP).

Education / Experience Requirements / Qualifications

• Advanced degree(s) (Master's, PhD, or equivalent) in statistics, biostatistics, or a comparable quantitative field.

Skills Required

• Strong statistical programming experience in SAS, R, Python.
• Proficient in using data analytic platforms such as MS Excel, JMP, and similar tools.
• Expertise in developing and applying animal models and in vitro assays.
• Knowledge of regulatory guidelines and GLP (Good Laboratory Practices).
• Ability to design, analyze, and interpret complex clinical and preclinical data.
• Expertise in providing guidance on statistical methodology for research and clinical studies

Competencies Required

• Ability to analyze and interpret complex quantitative data and provide actionable insights.
• Expertise in the application of advanced statistical methods in medical countermeasure (MCM) development.
• Understanding of GLP regulations and experience with studies adhering to these guidelines.
• Strong communication skills to present statistical findings to non-statistical stakeholders.
• Ability to work collaboratively within teams, providing expert advice and statistical recommendations

Ancillary Details Of The Roles

• Provide statistical support for all phases of MCM development, from preclinical testing to clinical trials.
• Serve as an advisor on the use of statistical techniques in the development of animal models, in vitro assays, and clinical studies.
• Review and provide feedback on study protocols, reports, and regulatory documents from a statistical perspective.
• Work with Contract Research Organizations (CROs) to ensure proper statistical methodology is applied in studies
• Develop and standardize statistical processes and methodologies across different therapeutic areas and BARDA's portfolio of MCMs.
• Lead or participate in the design of studies, ensuring the appropriate statistical methods are applied for regulatory submissions.
• Provide guidance on risk/benefit analyses and assist in decision-making processes related to MCM development.
• Support the development of market research efforts to assess statistical needs and methodologies for new projects

Other Details

• Senior SMEs should have extensive leadership experience in statistical oversight and advanced MCM development.
• Ability to distill complex statistical results into clear, concise, and actionable insights.
• Experience with high-level strategic planning and advising federal staff on the appropriate statistical approach for MCM programs.
• Strong expertise in working with regulatory agencies and understanding how statistical data fits into regulatory submission processes.
• Must have a thorough understanding of the development lifecycle for medical countermeasures against CBRN threats

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CORE COMPETENCIES

• Teamwork - ability to foster teamwork collaboratively as a participant, and effectively as a team leader
• Leadership - ability to guide and lead colleagues on projects and initiatives
• Business Acumen - understanding and insight into how organizations perform, including business processes, data, systems, and people
• Communication - ability to effectively communicate to stakeholders of all levels orally and in writing
• Motivation - persistent in pursuit of quality and optimal client and company solutions
• Agility - ability to quickly understand and transition between different projects, concepts, initiatives, or work streams
• Judgment - exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications
• Organization - ability to manage projects and activity, and prioritize tasks

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OTHER REQUIREMENTS

• Business Tools -  understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Commitment - to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors
• Curiosity - the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
• Humility - exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
• Willingness - to constantly learn, share, and grow and to view the world as their classroom

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BENEFITS AND HIGHLIGHTS

ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That's why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:

• Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.
• Group Medical Health Insurance Benefits: ProSidian partners with BC/BS...