Director - ECD Biostatistics

5 days left

Employer
Pfizer
Location
Remote, California, California
Salary
Competitive
Posted
May 03, 2021
Closes
May 11, 2021
Ref
545488
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Full Time
ROLE SUMMARY
  • The Director must possess the ability to plan, direct and coordinate a variety of specialized and complex translational research projects.
  • Must have -expertise in analysis of high dimensional datasets, omics/NGS technologies, design of experiments, programming tools, and the ability to statistically analyze data and interpret results from clinical and pre-clinical studies.
  • They must have familiarity with laboratory data storage and management systems.
  • The Director is a partner to the Translational Sciences, Discovery Technologies, and Oncology Research Units.
  • The Director directs the activities of Pfizer biostatisticians and contract biostatisticians who support Pfizer's oncology in-vivo/in-vitro preclinical and clinical biomarker efforts across multiple sites, directing the scheduling of work assignments, and monitoring project status to assure timely completion of projects.
  • The Director assures biostatisticians have direction, training, and mentoring in collaboration techniques to achieve successful interactions with research partners, statisticians, and operations colleagues.
  • As a member of the Non Clinical Statistics Leadership Team, the Director works closely with other members of Non Clinical Statistics to identify areas of shared interest and expertise and facilitates collaboration between statisticians across teams.
  • The Director should be a person of vision who will contribute to new developments and technological advancement in statistics, identify new methodologies to apply to biomarkers, recognize new technologies in biomedical research where statistics can make an impact, and participate in the development, dissemination and promotion of innovative data analysis pipelines.
  • Direct staff to provide scientifically rigorous statistical input into preclinical and biomarker study design, biomarker statistical analysis plans, assay development plans, interpretation of statistical and assay results, project development plans, regulatory issues and scientific and registration projects, while demonstrating and promoting good collaborative skills.
  • Review, approve, and provide planning and communication of statistical analyses, data presentations and scientific reports, including biomarker qualification and validation reports, exploratory and meta-analysis results, support for publication activities, scientific presentations and support to rapid responses.
  • Develop and promote effective collaborations with project teams, Translational Oncology, and other partner lines; identify areas of alignment with other non-clinical statistics groups (e.g. Discovery Genomics and Precision Medicine Statistics; In-Vivo/In-Vitro Statistics).
  • Proactively identify areas of unmet need within preclinical and translational oncology and increase statistical rigor and objectivity in decision-making.
  • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards Be up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the assigned Pfizer curriculum.
  • Provide practical input to the Pfizer Oncology Clinical Research Lab for study design, assay development, qualification and validation
  • Promote statistical thinking including Bayesian thinking in oncology research through presentations, short courses and collaboration.
  • Direct and contribute to tool development that will automate data visualization, analyses and reporting.
  • Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
  • Comply with all statistics and quality processes and Pfizer data standards that are applicable to statistical outputs and support processes that require statistical input.
  • Identify potential topics for research on statistical methodology and its applications pertinent to the Pfizer business needs and develop strategies for collaboration and execution of innovative ideas.


BASIC QUALIFICATIONS

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.

  • PhD in Statistics/Biostatistics or related field and at least 5 years of pharmaceutical experience or a Masters degree in Statistics/Biostatistics or related field and at least 10 years of pharmaceutical experience
  • Strong pre-clinical and non-clinical experience is required, including expertise in biomarkers (oncology preferred).
  • Capability to provide statistical leadership to cross-functional teams; ability to identify new areas for collaboration.
  • Expert knowledge in drug development regulations pertinent to statistical analysis; ability to negotiate with regulatory bodies.
  • Strong understanding of details of multiple assay technology platforms (e.g. IHC, NGS, Nano String, CRISPR, PCR)


PREFERRED QUALIFICATIONS
  • Proficient with R, SAS or other programming languages


PHYSICAL/MENTAL REQUIREMENTS
  • Strong communication skills and the ability to work collaboratively with research scientists are essential.
  • Demonstrated ability to work effectively as a part of a team.


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