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Associate Director, Biostatistics

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Apr 14, 2021

View more

Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

ROLE SUMMARY

This position will provide statistical support for clinical Phase I-IV projects in Vaccine Research and Development. The successful candidate will collaborate with study teams working effectively to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports, present results summarizing findings, develop publications of results, contribute to overall clinical development plan. The successful candidate would also participate in regulatory submissions and developing responses to regulatory queries. The candidate will directly contribute to Company success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, biomarker strategies and by implementing appropriate statistical methods to facilitate product development.

ROLE RESPONSIBILITIES
  • Provide scientifically rigorous statistical input into protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives.
  • Be accountable for study and program level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
  • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.
  • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • Develop effective collaborations with others within clinical teams and partner lines (such as Development Operations, Safety Risk Management, Regulatory).
  • Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
  • 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, learnings across divisions and locations, and activities for process improvements.


Qualifications

Candidate demonstrates a breadth of diverse leadership experiences and cap

abilities 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.

BASIC QUALIFICATIONS
  • M.S. degree in statistics, biostatistics or a related field with minimum of 8-year experience in applied statistics; Or Ph.D. degree in statistics, biostatistics or a related field with minimum of 4-year experience.
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities.
  • Capability to provide statistical leadership within cross-functional teams.


PREFERRED QUALIFICATIONS
  • Ph. D. degree in statistics or biostatistics.
  • Relevant experience in the design, implementation, analysis and reporting of clinical trials, especially for vaccine development programs, 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 modeling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable.


PHYSICAL/MENTAL REQUIREMENTS
  • Ability to perform mathematical and statistical calculations.
  • Ability to perform complex data analysis.


Other Job Details:
  • Eligible for Employee Referral Bonus: YES
  • Eligible for Relocation: YES


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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