Manager, Biostatistics

ROLE SUMMARY

This position will provide statistical support for a variety of specialized and complex research projects within Vaccines Medical. The successful candidate must have knowledge of clinical design of experiments, clinical data management and programming tools, and ability to interpret results from clinical and epidemiological studies. Successful candidate would also help the team participate in regulatory submissions and response to regulatory queries. The candidate will report to the Biostatistics Lead in Translational Research and contribute to Pfizer Vaccines MDSCA success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, and specifically by implementing appropriate statistical methods of enhanced quantitative vaccine development.

ROLE RESPONSIBILITIES

• Through effective partnership with lead project statistician, provide statistical input to study designs, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issue and scientific and commercialization projects
  
• Provide scientifically rigorous statistical input into planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical results. Exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense
  
• Accountable for study level and submission level statistical deliverables on assigned projects
  
• Develop effective collaborations with others within Clinical R & R 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 and Pfizer standards
  
• Comply with all statistical and quality processes and standards that are applicable to statistical outputs, and support processes and require statistical input
  
• Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approach
  
• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidance and their interpretation in practice.
  
• Participate in research on statistical methodology and its application pertinent to its business need.
  
• Contribute to the high-level decision making for Vaccine assets with respect to entire patient population decisions, label changes, dosing decisions, and individual study designs.
  
• Be up to date on SOP training and compliance with all Pfizer SOPs as required based on the assigned curriculum
  
• Comply with all statistics and quality processes and Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.
  
• Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learnings across divisions and locations.
  
• Able to provide timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions
  
• Strong analytic skills, well-organized, clearly documents what has been done, is aware of and adheres to relevant SOPs.
  
• Able to manage complex projects and cross-functional processes
  
• Familiar with and comfortable using deployed technologies and tools;
  
• Strong presentation and communication skills working with colleagues; able to effectively communicate technical material to non-technical audience; proactively proposes new ideas and able to refine ideas of others
  
• Excellent written and communication skills
  

QUALIFICATIONS

Must-Have

• T he qualified candidate must have a M.S. in Statistics or Biostatistics and a minimum of three years' experience in applying statistics in a pharmaceutical or related industry or a Ph.D. in Statistics or Biostatistics.
  
• Demonstrated experience and success providing timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions
  
• Knowledge of experimental design
  
• Strong understanding of the state-of-the-art technologies to evaluate and leverage them for improved business processes
  
• Aptitude to identify, understand, and apply relevant scientific literature
  
• Demonstrated strong written and verbal communication skills
  

Nice-to-Have

• R elevant pharmaceutical industry experience
  
• Ability to write comprehensive statistical analysis programs, as well as statistical section of complex research protocols; must be able to perform complex mathematical calculations and have theability to perform complex data analyses.
  
• 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.
  

Other Job Details:

• Last Date to Apply for Job: April 14, 2021
  
• Additional Location Information: Collegeville, PA preferred
  
• Eligible for Employee Referral Bonus
  

Sunshine Act

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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