Pfizer

Director Biostatistics

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
June 10 2021
Ref
4811255
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

The successful candidate must plan, direct and coordinate a variety of specialized and complex research projects within Vaccines Medical, 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 also participates in regulatory submissions and response to regulatory queries. The candidate directly contributes to company success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, biomarker strategies and by implementing appropriate statistical methods of enhanced quantitative vaccine development and real world research studies. This includes resource allocation, directing the scheduling of work assignments, and monitoring project status to assure timely completion of projects.

This position is for the personal to work as the Vaccine asset statistical lead, serve as the voting member of MSC and other governance committee to review CDI vaccine research proposals Serve as the study level statistician for studies, outpatient study within the asset responsible, Serve as the study level statistician for other asset, working the asset statistical lead, Contributor of the statistical function training material for on-boarding new statisticians Co-authorship of manuscripts for peer reviewed publications.

ROLE RESPONSIBILITIES
  • Provide scientifically rigorous statistical input into regulatory strategy, medical development plans, epidemiology plans, protocol development, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans, business development opportunities and other product support projects.
  • Be accountable for study level and statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
  • 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.
  • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • 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.
  • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support and authorship for publication activities, scientific presentations, and support to product defense.
  • Identify opportunities to utilize innovative statistical methodology to facilitate optimal decision-making.
  • Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs
  • 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.
  • 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.
  • Provide input to the Senior Director of Statistics to plan support for assigned studies and vaccine asset lead effort.
  • Train new statisticians in Translational Research


QUALIFICATIONS
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities
  • Advanced degree in statistics, biostatistics or a related field: M.S. or Ph.D. plus minimum of 4 year experience in applied statistics; at least 2 years experience of vaccine experience
  • Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations:
  • Track record of applying advanced statistical skills to clinical trials and submissions
  • Knowledge and application of statistical modelling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable.Strong statistical skills with application to observational studies and utilizing real world data clinical trials.
  • Scientific publication review
  • Capability to provide statistical leadership within cross-functional teams at the protocol and project level.
  • Hands on ability to perform complex data analysis and statistical calculations using statistical analysis software.
  • 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.


Organization responsibility
  • Reports directly to Head of Translational Research, Biostatistics.
  • Peer with other statisticians within Vaccine Clinical Research, interact directly with Clinicians, Programming and Data Management, Regulatory, Medical, Outcomes Research, epidemiologist, Commercial, Operations, and contract organizations supporting project deliverables.


Other Job Details:
  • Last Date to Apply for Job: June 23, 2021
  • Additional Location Information:
  • Eligible for Relocation Package


Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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