Manager, Translational Biomarker Statistics

ROLE SUMMARY 

This position is for a biomarker statistician in the Translational Biomarker Statistics (TBS) team which is under the Statistical Research and Data Science Center (SRDC) within the Global Biometrics and Data Management (GBDM) organization in Pfizer Global Product Development (GPD). In this role, the biomarker statistician provides technical support in terms of experimental design, data analysis, output generation and statistical interpretation of biomarker data from late phase oncology clinical trials and external collaborations projects. The biomarker statistician works independently with Translational Oncology (TO) leads to deliver analytical support for biomarker data sets informing clinical trials and testing research hypotheses. Skill sets required for this role include fundamental knowledge of statistical analysis and design, demonstrated ability to create computational tools for data analysis and visualization, familiarity with modern multi-dimensional ‘omics data technologies and basic understanding about use of biomarkers in clinical contexts. 

ROLE RESPONSIBILITIES 

• Collaborate with various GPD scientists in the design, analysis and reporting of biological and ‘omics data from target identification, assay development and exploratory biomarkers from late phase clinical oncology programs 

• Build tools and pipelines for both scientists and statisticians to perform routine analyses, to report and visualize data and to support large-scale ‘omics data analysis 

• Collaborate with TO leads and clinicians in the design, analysis and reporting of multi-dimensional biomarker data in late phase clinical trials, including assistance with visual summarization, interpretation of results, writing of the biomarker Statistical Analyses Plans to enable objective decision-making for each clinical program 

• Defines and evolves best practices across the group and partners with ORU, Business Technology (BT) and bioinformatics experts to align approaches, develop best practices and assess and develop new technology 

• Collaborate with research unit scientists in the design, analysis and reporting of genetics and ‘omics analyses to enable robust decisions to be made from our clinical trial data 

• Partner closely with Clinical Teams, Statistics, BT and TO functions to identify, pilot and incorporate new bioinformatics tools to support clinical trials 

• Bring innovative statistical thinking including Bayesian thinking in oncology research through presentations, short courses, and collaboration 

• Represent statistics function on cross-line teams 

BASIC QUALIFICATIONS  

• Advanced degree in Statistics, Biostatistics, Bioinformatics, computational biology, statistical genetics, data science, or related field. 

• At least 4 years of relevant biomarker data analysis in clinical trials and business experience 

• At least one full year experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems.  Pharmaceutical or biotech applications desired. 

• Able to effectively manage a diverse and dynamic workload 

• Programming skills in R (preferred) or SAS with expertise in big data, data visualization and web based applications. 

• Strong working knowledge of high dimensional exploratory biomarker platforms (e.g. transcriptomics, proteomics, flow cytometry, etc.) 

• Strong knowledge and understanding of statistical analytical methods that may be applied to genetics and omics data analysis. 

• Strong understanding of clinical study design principles and familiarity working with clinical data in a clinical trial setting. 

• Familiarity/expertise in meta-analysis and potential issues surrounding combining results from different studies, both from a design perspective and in terms of subject ascertainment.   

• Experience running simulations and mixed models. 

• Demonstrated ability to develop, influence and champion statistics thinking with scientific team audiences and management.  

• Excellent interpersonal and verbal and written communication skills; ability to clearly convey statistical and bioinformatics principles and results to non-experts. Experience presenting to multi-disciplinary scientific audiences. 

PHYSICAL/MENTAL REQUIREMENTS 

• Familiar with and comfortable using deployed technologies and tools; identifies new opportunities and emergent needs and acts on them 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS  

May be required to travel internationally for project meetings and conferences 

ORGANIZATIONAL RELATIONSHIPS 

• Reports operationally to the Head of Statistics for India and Philippines and functionally to Head of Translation Biomarker Statistics group 

• Works within other TBS statisticians, biomarker programmers, clinicians and study statisticians. 

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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