Senior Manager Biostatistics - Early Clinical Development, Pfizer
Fantastic opportunity at Pfizer to apply statistical methods and quantitative thinking to early phase clinical trials. Located at our Cambridge, UK or Cambridge, US sites (remote working also considered). https://pfizer.wd1.myworkdayjobs.com/PfizerCareers/job/United-Kingdom---Cambridge/Sr-Manager-Biostatistics--ECD_4809278
Purpose
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. The statistician will support the development of innovative and efficient plans for developing new medicines in the Internal Medicine Research Unit, which is currently focussed on treatments for Cardiovascular and Metabolic Diseases. 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
* Provide statistical input into study design, analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific projects
* Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, and scientific presentations
* Provide statistical expertise and contributions for projects and protocols in support of WRD goals with a focus on delivering high quality, actionable PoC data
* Provide statistical expertise to maximizing the value of aggregate clinical data in support of scientific and drug development strategies
* Provide study level statistical leadership
* Accountable for statistical deliverables on assigned projects
* Develop effective collaborations with others for programs (PDM, PK/PD modelers, clinicians and pharmacokineticists), and external regulatory, industry, professional and academic organizations
* Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements, Pfizer and WRD standards
* Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, RPLs, Biometrics and Data Management colleagues – for assigned studies and regulatory submissions
* Provide oversight to CROs supporting WRD programs
* Provide input to the RPL to plan support for assigned studies and submissions.
* Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects
* 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
Training, Education and Experience Preferred:
* Advanced degree in statistics, biostatistics, or related field
* Capability to provide statistical leadership to cross-functional teams
* Experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems.
* 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.
* Demonstrated strong communication skills, both oral and written.
* Demonstrated ability to work effectively as a part of a team.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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Closing Statement
This position holds a Global Job Level 090 and UK Grade 13
The closing deadline for applications is 23rd June 2021
We will only accept applications from colleagues via the formal route within Workday. Please do not submit paper or e-mail applications.
