Sr Manager, Biostatistics

Collegeville, Pennsylvania
April 27 2021
Position Type
Full Time
Organization Type
Job Type
  • The successful candidate will collaborate in the development and post-approval environment through consultation and implementation of statistical techniques related to Vaccine translational research projects. The candidate will have statistical expertise in value-based drug development among medical affair scientists, statisticians, and clinicians through active engagement and leadership in research methodology and content-specific areas. He/She will design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices. Provide scientifically rigorous statistical expertise on:
  • Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products;
  • Projects to maximize the value of aggregate clinical and real-world data in support of drug development and other scientific strategies.
  • Provide study and other project level statistical counsel and communicate resource needs to teams.

  • Provide scientifically rigorous statistical input into Asset level regulatory strategy, medical development plans, epidemiology plans, regulatory questions, interpretation of statistical results, study design, statistical analysis plans, business development opportunities and scientific and commercialization projects
  • Understand the major medical issues for the vaccines and involved
  • Provide statistical input and leadership to cross-functional activities under appropriate business models - collaborate with other statisticians, study managers, Vaccines colleagues - for assigned studies and regulatory submissions, including allocation of resources to provide services in line with company priorities, and monitoring progress towards timely completion of services.
  • Provide planning, deliveryand communication of statistical analyses, data presentations and scientific reports, includingclinical trial results, exploratory analyses and analyses that synthesize results across studies, utilizing real world data, support for publication activities, scientific presentations and support for product defense
  • Be accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards
  • Identify opportunities to utilize innovative statistical methodology to facilitate optimal decision-making. Participate in research on statistical methodology and its applications pertinent to Pfizer's business needs
  • Develop effective collaborations with colleagues within clinical teams, partner lines (such as GPD, , Regulatory, Outcomes Research) and external regulatory, industry andprofessional and academic organizations
  • 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 areapplicable to statistical outputs, and support processes that require statistical input.
  • Provide input to the Senior Director of Statistics to plan support for assigned studies and submissions.
  • Communicate and collaborate with other project statisticians within Pfizer to ensure consistency of statistical approaches across studies and alignment with approaches used in epidemiological studies and regulatory submissions.
  • Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learnings across divisions and locations.

  • Advanced degree in statistics, biostatistics, or related field. M.S. in Statistics (or related field) plus minimum of7 years experience in applied statistics; or Ph.D. in Statistics (or related field) plus minimum of4 years experience in applied statistics. Candidates with less work experience, or experience in other fields, will also be considered if they have exceptional methodology research credentials and potential.
  • Relevant pharmaceutical research/clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.
  • Candidate demonstrates a breadth of diverse experiences and capabilities including: the ability to effectively collaborate with peers, develop and contribute to pharmaceutical research projects proposal, oversee and guide the work of research team to achieve meaningful outcomes and create business impact.

  • Experience with advanced knowledge of real-world evidence/epidemiology study analysis, and conjoint analysis
  • Proficient with subject matter content in Vaccine development/recommendation evidence generation
  • Experience with different phases of drug development, from Phase 2 to Phase 4, and the associated regulatory and other business requirement involved
  • Evidence of creative thought-leadership, professional presence, and scholarship through publications and presentations
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
  • Broad-based understanding of statistical theory and its application
  • 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: May 7, 2021
  • Eligible for Relocation Package

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.



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