Executive Director Biostatistics-Internal Medicine Research Unit, Early Clinical Development

ROLE SUMMARY

Reporting to the Vice President, Head of Biostatistics, Early Clinical Development (ECD), this role is responsible for leading statistical colleagues to provide innovative, high quality statistical input and critical review of projects. He/She will be responsible for all the statistical components from lead series development and candidate nomination through Proof of Concept (POC). This will include overseeing early clinical development plans, study designs, analysis and reporting through to PoC. S/He will serve as the ECD Statistics representative and primary point of contact for one of Pfizer's core research units (Internal Medicine). S/He will be a champion for pre-clinical and early clinical development needs and approaches within the research unit and associated platform lines. S/He will be responsible for the design and development of project plans and regulatory strategies, the planning & delivery of statistical analyses, data presentations, and scientific reports for clinical trial results, product defense as well as regulatory, commercial support as needed and for scientific presentations/publications in conformance with good statistical practices and with the FDA and ICH guidelines. This individual is comfortable with project related work and may serve on projects teams as needed.

Statisticians in Early Clinical Research require related but differing technical competencies and must operate within, and frequently across, multiple domains. These include:

• translational research within and between animal and human disease models
  
• precision medicine
  
• early clinical biostatistics
  
• application of MIDD principles wherever appropriate along the target-to PoC continuum.
  

The majority of these domains represent steps along the lead development-to-PoC continuum and for which the key outcome is delivery of positive PoC studies. However, the same collaborative behaviors and personal leadership is expected of all Statisticians. Alignment and communication with statistical colleagues are critical, as is strong collaboration and interaction with research scientists, chemists, biologists, late development statisticians, clinicians, pharmacologists, pharmacometricians, PDM modelers, and regulatory specialists.

ROLE RESPONSIBILITIES

Technical Contribution to Projects:

• Lead a team to provide high quality statistical input and critical review of projects from LD and CAN through POC. Lead the development of innovative approaches to achieve more efficient and successful PoC / ESOE through MIDD methods, Bayesian approaches, and similar.
  
• Provide statistical expertise and advice to the Research CSO's to guide key investment decisions.
  
• Oversee the application of appropriate statistical methodology in conformance with good statistical practices and with the regulatory (ICH) guidelines.
  
• Identify suitable statistical resources to provide high quality and timely support for the Due Diligence activities for in-licensing opportunities.
  
• Lead the development of approaches to develop MIDD methods in the preclinical and clinical setting.
  
• Represent statistics in the early clinical development protocol review committee and ensure quality of all statistical aspects in the clinical trial protocol
  
• Ensure Alignment of Biometric component and ensure consistent support of Biometrics from Pfizer Development China
  
• Ensure cross-RU learnings through proactive engagement and statistical training
  
• Partners with global heads and local leaders of RU's and partner lines as required
  
• Application, development and advancement of Pfizer-wide clinical statistics best practices and overall support of Pfizer-wide clinical statistics community
  
  • Provide guidance to author/update Pfizer Global Clinical Statistics Guidance documents and other similar initiatives
    
  • Proactively improve efficiencies in early clinical development statistics and across the ECD organization
    

Development and Implementation of Best Practices:

• Lead statistical colleagues to ensure (i) industry-leading statistical best practices, and (ii) excellence in consultation, are applied uniformly for all projects within the TA cluster.
  
• Promote and exemplify the MIDD principles and the culture of operating effectively in the triad.
  
• Develop and gain endorsement for consensus thinking around landmark study designs (e.g., by indication).
  
• Develop and promote an effective Statistical network with other Pfizer statisticians supporting Research.
  
• Work with late development clinical team to ensure seamless transition of projects.
  
• Work effectively across the global discipline in formulating and implementing global statistical policies, including those for standards.
  
• Provide a strong presence in regulatory and professional circles to influence the content of regulatory guidelines and their interpretation in practice; and encourage/sponsor research in statistical methodology and its applications pertinent to business needs.
  
• Lead technical statistical review meetings pre-TRC to ensure best practices, appropriate statistical rigor and consistent approaches to design are implemented.
  
• Represent ECD at the extended Leadership Team for Biometrics and Data Management to advocate for the unique requirements of research clinical trials in the global development.
  

Management:

• Recruit, train, develop, mentor, motivate and retain highly skilled statisticians to provide effective and qualified resources to support Research objectives and projects.
  
• Ensure the statisticians work effectively work across the organization to provide high-quality statistical input to design and interpretation of projects and studies.
  
• Ensure that the statisticians work effectively with Biologist, Chemist, Clinical Pharmacologists, Clinicians and others within the project teams to provide high-quality statistical input to design and interpret analyses for programs and studies.
  
• Provide leadership to meet time, quality, and cost targets consistent with being an efficient and effective business unit.
  
• Supervision: 5-10 reports
  
• Collaborate with Research Statistics colleagues globally to effectively load share to meet business demands. Make effective use of alternative resourcing options including FSPs and Asia.
  
• Collaborate with Statistics Management globally to effectively allocate resources (human and capital) t o meet Business demands. Make effective use of alternative resourcing options including contractors and academic collaborations.
  
• Implement organizational design and develop succession planning for the Statistics function within ECD in collaboration with the Head of ECD Statistics.
  
• Align and motivate staff behind the overall direction of WRD.
  
• Contribute to the continuous improvement of the drug development process
  
• Contribute to the articulation of appropriate standards and specifications for input to contracts with vendors, suppliers and industry partners to deliver the project.
  

QUALIFICATIONS

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• Advanced degree in statistics, biostatistics, or related field required (PhD Preferred)
  
• 10+ years of experience in drug development
  
• Relevant clinical trial, scientific and business knowledge providing an understanding of the objectives and processes associated with drug discovery, pre-clinical development, and early clinical development. Familiarity with late-stage development is desirable
  
• Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences across the early research and development area
  
• Strong statistical skills with application in at least one of the following areas: target discovery/validation, lead compound development, computational chemistry/biology, translational research (including imaging and biomarker development/validation), molecular medicine, clinical enabler studies, and early clinical drug development.
  
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  
• Proven ability and prior experience in managing colleagues
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Office based work

10-15% travel

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#LI-PFE

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