Pfizer

Director, Biostatistics

Employer
Pfizer
Location
La Jolla, California; Boulder, Colorado; New York City, New York; Collegeville, Pennsylvania
Salary
Competitive
Posted
April 05 2021
Ref
4802866
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY
  • Plan, direct and coordinate a variety of specialized and complex global development projects
  • 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; Regulatory and Health Technology Assessment (HTA) submissions; and 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.
  • Roll out new initiatives and assists in strategic planning.


ROLE RESPONSIBILITIES
  • Provide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
  • 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.
  • Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects.
  • Develop effective collaborations internally and externally including, but not limited to, clinical teams, partner lines, regulatory, payer, industry, professional and academic organizations.
  • Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • Maintain compliance with all required training.
  • Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or regulatory and HTA submissions.
  • Provide input to Statistics Group Lead and/or Statistics Group Head to plan support for assigned projects, studies, and submissions.
  • Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.
  • Communicate and collaborate with other project statisticians within GPD, or other organizations where applicable, to ensure consistency of statistical approaches across studies and alignment with approaches used in regulatory submissions.
  • Present 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.


BASIC QUALIFICATIONS
  • Advanced degree in statistics, biostatistics, or related field.
  • A minimum of 8 years of experience in the clinical trial setting.
  • Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations.
  • Capability to provide statistical leadership to cross -functional teams at the protocol or project level.
  • Strong statistical skills with application to clinical trials especially survival analysis methodology.
  • Effective verbal and written communication skills.
  • 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:
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES


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For roles based in Colorado:

The annual base salary for this position ranges from $ 146,500 to $244,100 . In addition, this position offers an annual bonus with a target of 20% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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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