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Executive Director, Biostatistics RU Group Head, Early Clinical


Cambridge, MA
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Job Title Executive Director, Biostatistics RU Group Head, Early Clinical

JobID 1046647-1852

Location: Cambridge, MA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

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, e.g. Neurosciences, Inflammation & Immunology (I&I), Rare Diseases, Cardiovascular/Metabolic and Oncology. 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 ECTD/EQDD and EQDM 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 is critical, as is strong collaboration and interaction with research scientists, chemists,biologists, late development statisticians, clinicians, pharmacologists,pharmacometricians, PDM modelers, and regulatory specialists.#LI-SA1


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 EQDD 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 EQDD methods in the preclinical 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*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 clinical statistics and across the ECD organizationDevelopment 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 ECTD/EQDD 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 Biometrics and Data Management forums 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 interpretation of programs and studies. *Provide leadership to meet time, quality, and cost targets consistent with being an efficient and effective business unit.*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) to 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.*10-15 % travel may be needed


*Advanced degree in statistics, biostatistics, or related field required (PhD Preferred)*10 years of experience in drug development #LI-SA1*At least 5 years of Oncology experience preferred*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 audience 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

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Executive Director, Biostatistics RU Group Head, Early Clinical*
*Cambridge, Massachusetts*

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