Pfizer

Sr Director, Biostatistics, Translational Research

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
January 07 2021
Ref
4800970
Position Type
Full Time
Organization Type
Pharma
POSITION SUMMARY

The Sr. Director, Biostatistics (SDB), must possess the ability to plan, direct and coordinate a variety of specialized and complex research projects, must have knowledge of clinical design of experiments and studies, clinical data management and programming tools, and ability to interpret results from clinical and epidemiological studies. The SDB should have ability to roll out new initiatives and contribute to strategic planning for each asset.

The SDB must be able to be a part of, and potentially co-lead or lead a team of statisticians, programmers and vendors to support all activities around development of the vaccine development through long term post approval surveillance. The SDB eed to demonstrate l eadership and high - level input in the design, interpretation and strategy for development and medical support of varied stage of vaccine development, include the early compounds development (pre-clinical), POC and licensed vaccines for a portfolio of several vaccines in a global arena.

The primary purpose of this role is the strategic decision making and statistical support of global phase IV clinical studies and epidemiology (pre-POC thru post marketing) vaccine programs for the Medical Development Scientific and Clinical Affairs organization in the Vaccines Franchise. Additional responsibilities would include support of earlier phase clinical studies, supervision of direct reports, input into scientific communications (publications, abstracts, product defense), target patient populations, regulatory strategy, support of business development activities and all analyses in the phase IV space.

POSITION RESPONSIBILITIES
  • Lead or co-lead a growing team of statisticians and programmers both direct reports and in dotted line matrix relationships to support the objectives of MDSCA globally.
  • Provide scientifically rigorous statistical input into regulatory strategy, clinical development plans, epidemiology plans, regulatory questions, interpretation of statistical results, study design, statistical analysis plans, business development opportunities and scientific and commercialization projects.
  • Be accountable for directing teams to complete study level and statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
  • Contribute significantly to the high - level decision making for Vaccine assets with respect to entire patient population decisions, label changes, dosing decisions, and individual study designs.
  • Understand the major medical issues for each of the vaccines.
  • Develop effective collaborations with Pfizer enterprise organizations and others within MDSCA including the regions, clinical teams, partner lines (such as DevOps,Market Access, SRM, Regulatory), 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.
  • 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, scientific presentations, and support to product defense.
  • Be up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the assigned curriculum
  • Provide statistical input and leadership to cross-functional activities - collaborate with other statisticians, study managers, Vaccines colleagues - for assigned studies and regulatory submissions
  • Comply with all statistics and quality processes and Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.
  • 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.
  • Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
  • Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs.
  • Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learnings across divisions and locations.


ORGANIZATIONAL RELATIONSHIPS

As a key member of the Vaccines medical organization will interact directly with Clinical (Clinicians), Medical Monitors, MDSCA leadership, Epidemiology, Research Unit, Regulatory Strategy and Operations, Medical, Outcomes Research, Commercial, Operations, Development Operations and contract organizations supporting project deliverables. Will report to head of Global Vaccines Translational Research Lead.

EDUCATION AND EXPERIENCE
  • Advanced degree in statistics, biostatistics, or related field. M.S. in Statistics (or related field) plus minimum of 10 years of experience in applied statistics; or Ph.D. in Statistics (or related field) plus minimum of 5 years of experience in applied statistics.
  • Requires 10 years of relevant vaccines clinical trial and epidemiological experience.
  • Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.


TECHNICAL SKILLS REQUIREMENTS
  • Strong statistical skills as applied to epidemiology, clinical trials and submission.
  • Knowledge and application of meta-analysis and other complex modeling approaches using a variety of data sources is recommended.
  • Capability to provide statistical leadership to cross-functional teams.
  • Ability to be an effective people manager and leader in a matrix environment
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities.
  • Scientific publication review
  • 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: January 13, 2021
  • Additional Location Information: Travel to Collegeville, PA, NYC and, sporadically, international travel will be likely
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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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