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Associate Director, Biostatistics - Early Clinical Development

Employer
Pfizer
Location
Cambridge, MA
Start date
Jul 14, 2022

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Job Details

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

ROLE SUMMARY

Biostatisticians play a critical role in the advancement of new medicines at Pfizer. The right candidate will partner with clinicians, clinical pharmacologists, translational medicine, and other scientists to support drug development in Pfizer’s Early Clinical Development (ECD) unit. This role is for a statistician to support the development of innovative and efficient plans for developing new medicines in the Inflammation and Immunology (I&I) Research Unit. There will also be opportunities to support the expanding anti-infectives portfolio. The statistician will be involved in the design, analysis, and reporting of clinical protocols covering early clinical development from first in human through proof of concept/phase 2b.

ROLE RESPONSIBILITIES

  • Collaborate with various scientists in the design, analysis and reporting of laboratory and early clinical studies (typically through Phase II).

  • Core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality environment.

  • Interact with internal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types.

  • Leader to bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Pfizer. Central to this approach is the systematic review of prior information, statistical model building and simulation, utilizing Bayesian methods as appropriate, to design more effective studies.

  • Interact with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need.

  • Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives.

  • Use statistical expertise to influence both internal and external reports and presentations, with the aim to improve the quality of internal decision making and increase our influence on the external environment.

  • Provide high quality support for due diligence activities for in-licensing opportunities

  • Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input

BASIC QUALIFICATIONS

  • M.S. degree in Statistics (or related field) with minimum 5 years’ relevant experience, or PhD in Statistics (or related field) with at least 3 years’ relevant experience in applying statistics in a pharmaceutical or related industry.

  • Experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems.

  • Experience with modeling and simulation.

  • Must be able to explain statistical techniques and considerations to non-statisticians.

  • Capability to provide statistical leadership to cross-functional teams

  • Demonstrated strong communication skills, both oral and written.

  • Demonstrated ability to work effectively as a part of a team.

  • 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.

PREFERRED QUALIFICATIONS

  • Strong computational skills in R or SAS or other statistical applied software systems.

  • Prior experience providing statistical support to early phase clinical studies preferred.

  • Experience in using or sound understanding of the value of Bayesian methods in scientific research preferred.

  • Prior experience providing statistical support to clinical studies in inflammation, immunology or anti-infectives is a plus.

OTHER JOB DETAILS

  • Eligible for Employee Referral Award

  • Eligible for Relocation Package (Only U.S. based candidates who qualify for a move to Cambridge, MA per policy guidelines)

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Medical

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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