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Data Science Consultant
The Head of Data Science oversees key analytical functions for patient data, working to realize value-creating synergies in our analytical efforts. Under this function are the Biostatistics, Statistical Programming, Clinical Data Management, and Patient Reported Outcomes (PRO) groups.
The Head of Data Science will play a critical role in creating the company's strategy for the analysis of clinical information in clinical trials and other patient observational data sources, and will maximize the impact of Data Science through effective team leadership, strategic project management and prioritization, able to address potentially divergent needs of various stakeholders. The Data Science function will support key design and analysis activities in Clinical Development and Medical Affairs, overseeing an integrated approach to biostatistics, programming, data management, health outcomes research and patient reported outcomes. This role is responsible for evaluation of novel methodologies which may include adaptive designs for clinical trials, use of modeling and simulation techniques, incorporation of preclinical and clinical predictive biomarker strategies to support precision medicine approaches and patient selection strategies, cross-functional integration of data analysis, implementation of key processes and mentoring of colleagues. This individual will play an active role in supporting ongoing clinical & preclinical research and regulatory activities and will interface extensively with stakeholder functions to effectively integrate across all R&D functions. Additional responsibilities include the maintenance and evolution of the existing systems and processes involved in the collection, review and analysis of clinical data, and driving effective collaboration with Partners.
The Head of Data Science will be responsible for leading PRO development efforts and working across functions to implement PRO strategies that meet the needs of key stakeholders, as well as the requirements of regulatory agencies.
Additionally, the Head of Data Science will lead product HEOR strategy development, implement projects supporting creation and delivery of value dossiers, and support appropriate business client interactions that are intended to secure optimal access and price for medicinal products.
This role is accountable for study designs, analyses, and reports that incorporate medical scientific, clinical development, and commercial brand strategies, and meet the needs of internal and external stakeholders in a high quality, compliant fashion and consistent with the mission and best practices.
· Supervise and manage all major Data Science activities to meet key milestones, maintain timelines, and keep within agreed budgets
· Responsible for the management of both internal and external statistical programming, biostatistician, data management, PRO and HEOR resources
· Create a long-term strategy to optimize the efficiency of organizational utilization models for outsourcing vs. insourcing to support drug development programs
· Work with other members of scientific leadership to integrate across all R&D functions
· Ensure all activities are in compliance with relevant FDA and ICH guidelines and follow relevant data management, statistical and PRO GCPs, and meet or exceed industry quality standards
· Contribute to the strategic planning of clinical development programs
· Work closely with Clinical Research, Clinical Operations, Pharmacovigilance, Regulatory, and Medical Writing to support optimal clinical trial strategy, design and execution, and to develop and execute PRO and HEOR strategies, including leading the development and validation of new PRO and HEOR instruments and their inclusion as appropriate in all programs
· Provide oversight for design, development, review and approval of randomization plans, statistical analysis plans, database design, data management plans, data collection guidelines, quality control and audit plan, and other data science documents
· Develop innovative analysis strategies for clinical data, applying advanced statistical methods as relevant
· Assure resolution of all statistical related issues with regulatory agencies and relevant Partners
· Work with external key opinion leaders and regulatory agencies to ensure PRO endpoints for clinical trial programs meet the needs of global regulatory agencies and key stakeholders
· Work with Publication Committee partners to develop a publication plan and to prepare and communicate clinical, outcomes and PRO data to physicians, patients, payers and policy makers
· Participate in the evaluation of new programs and products under consideration for in-licensing
· Formulate HEOR research projects that incorporate a brand-specific HEOR program strategy that integrates with MSA strategy, typically in collaboration with corporate partners
· Effectively integrates HEOR into clinical development and commercialization programs; ensures products are supported by patient-focused, evidence based value propositions
· Appropriately applies research methods to address hurdles for product registration, pricing, reimbursement and access
· Manage the prioritization and conduct of HEOR projects including requests for proposals, proposal assessments, and vendor selection, ensuring production of high quality research project results
· Develop medical cost and healthcare utilization models
· Interact with Payer / Managed Markets clients in compliance with laws, regulations, and policies governing institutional customer interactions and data use
· Ensure that instruments for development programs reflect outcome measurement best practices and meet the needs of key stakeholders, including the competent authorities in ICH regions
· Work with external key opinion leaders and regulatory agencies to obtain guidance on clinical outcomes assessment strategies
· Establish regulatory intelligence for instrument development and study endpoints in ICH regions
· Effectively communicate project status to Program teams, Management, and Corporate Partners to keep them informed of progress, budget and timeline implications, and important project results
· Provide resources and education across the organization on clinical outcome, PRO and HEOR assessments and their potential strategic impact on pipeline
· Lead development and implementation of Data Science SOPs across disciplines, and general standardization and quality assurance efforts within the function
· Manage and build Data Science team capabilities, providing training, mentorship and development to direct reports
· Recruit and retain high quality data science staff needed to achieve pipeline objectives
· PhD in statistics or biostatistics or related field
· 10 + years of management experience in pharmaceutical or biotech drug development, spanning IND through regulatory approval to life cycle management, with proven operational expertise
· 10 + years of broad experience in biostatistics, statistical programming, clinical data management, endpoint and outcomes research, including PROs and HEOR
· A proven ability to thrive in several critical areas including a track record of proven leadership, expertise in biostatistics, programming, data management, HEOR, PROs, and clinical trial design and endpoints
· Exceptional program/project leadership, team-building, and collaborative management skills; able to manage and prioritize numerous concurrent projects to successfully meet diverse requests from internal stakeholders, Partners, and external clients to provide results on time and on budget
· Experience working directly with the FDA on PRO development for a clinical development program
· Strong knowledge of and experience with PRO instrument development and implementation of corresponding research methodologies
· Experience working effectively in a cross-partner, cross-functional, project team environment and with key opinion leaders, regulatory agencies and other external stakeholders
· Understanding of key institutional stakeholders for HEOR: payers, reimbursement authorities, and healthcare systems (US and international)
· Good understanding of FDA and ICH regulatory requirements (as applied to data science activities and study design).
· Experience in building and leading teams in a style that emphasizes integrity, results, collegiality and effective teamwork, and in developing process, structures and competencies to enhance operational efficiencies and the quality of the team's deliverables.
· Displays strong critical thinking and analytical abilities, and scientific balance in hypothesis-driven and hypothesis-generating research activities
· Strong oral and written communication skills, with the ability to communicate effectively to internal and external audiences
· Strong organizational, problem solving and analytical skills, and creativity
· Flexible, able to adapt quickly as company priorities change
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
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