Pfizer's Early Clinical Development Statistics organization is looking for a motivated and experienced statistician with a solid background in nonclinical statistics, strong consulting skills, and an interest in collaborating with research scientists in drug discovery and development. The statistician in this role will work closely with research scientists seeking to discover new medicines in a variety of therapeutic areas by supporting the design and analysis of preclinical experiments covering all aspects of drug discovery from disease target identification, pharmacology studies, animal model development, biomarker development and demonstration of proof-of-concept. The focus will be on both “platform” approaches (i.e. ensuring robust assay methods) as well as specific project approaches. The ideal candidate will have a genuine interest in understanding drug target biology in order to provide effective statistical consultation with biological scientists, as well as effective communications with lab managers and regulators.
Drive collaborations with vaccine assay specialists to support vaccine clinical and diagnostic assay development, qualification, and validation
Drive collaborations with vaccine preclinical scientists to support vaccine preclinical and nonclinical development
Ensure statistical rigor and good scientific practices are followed, excellent statistical methods utilized, and documented in protocols, analysis plans and manuscripts
Provide statistical expertise to regulatory submissions and ensure quality and appropriateness of submission deliverables
Lead innovative statistical thinking and methods to maximize the value of aggregate clinical and preclinical data in support of scientific and vaccine development strategies
Serve as a core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality manner
Where possible, standardize processes and methodologies, may include developing statistical tools to aid scientists in standardized analyses.
Use statistical expertise to prepare both internal and external reports, presentations and manuscripts, with the aim to improve the quality of internal decision making and increase our influence on the external environment
Mentor and train junior level staff
PhD in Statistics/Biostatistics and at least 6-10 years of pharmaceutical experience or a Master degree in Statistics/Biostatistics and at least 10-15 years of pharmaceutical experience
Strong pre-clinical and non-clinical experience is required
Must have strong technical competence, including statistical computing and modeling
Capability to provide statistical leadership to cross-functional teams
Sound understanding of design of experiments, assay development, and statistical applications for preclinical research
Good knowledge of drug development regulations pertinent to statistical analysis
Demonstrated strong communication skills, both oral and written
Preferred candidates will have good computational skills in SAS and R
Ability to work collaboratively with research scientists are essential
Demonstrated ability to work effectively as a part of a teamand proactively influence teams with innovative assay development and validation strategy
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.
Assay validation experience, particularly clinical assays, is highly desired
Vaccine development experience is highly desired
Experience responding to regulatory queries is desired
OTHER JOB DETAILS
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EEO & Employment Eligibility
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