Pfizer Statistics Lead in Market St ,San Francisco, California
Seeking individual contributor who is responsible for all statistical aspects of assigned studies including design, analysis, and interpretation of clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.
Provide scientifically rigorous statistical expertise and contributions by working effectively within the clinical study team and partnering with other stakeholders (e.g., clinicians, safety specialists, pharmacokinetics specialists, Global Health and Value [GH&V]) on:
Projects and protocols in support of clinical development and for publication, presentation, and other evidence generation efforts for Pfizer products.
Regulatory and Health Technology Assessment (HTA) submissions, ensuring quality and appropriateness of submission deliverables.
Provide study and other project level statistical counsel and communicate resource needs to teams
This position reports to Director, Biostatistics.
Provides scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
Provides 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 study or project level and submission level statistical deliverables on assigned projects.
Accountable for implementation of quality, productivity, and other best practices, including close collaborations with other stakeholders.
Develops effective collaborations with others within clinical teams and/or GH&V colleagues, partner lines (e.g., Medicinal Sciences, Worldwide Safety & Regulatory), and external regulatory, payer, industry, professional and academic organizations.
Ensures that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
Keeps up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the assigned curriculum.
Provides 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.
Provides input to the Statistics Group Lead and/or Therapeutic Area Statistics Head to plan support for assigned studies and submissions.
Ensures timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
Complies with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.
Communicates and collaborates 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 phase III regulatory submissions.
Provides a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
Participates in research on statistical methodology and its applications pertinent to the Pfizer business needs.
Helps maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions.
Ph.D in statistics with 3 years of industry experience or MS in statistics with 7 years of industry experience
Proficiency in SAS, R or S+, East
Understands roles of Biostatistics, Statistical Programming and Data Management and provides adequate statistical expertise within a cross-functional team in clinical development
Experience with analysis and reporting of phase 2 and phase 3 study data, as well as integrated summary of efficacy and safety (ISE and ISS)
Experience with group-sequential designs and support of independent data monitoring committee for registration trials
Experience with statistical methodology and analysis for clinical trials in oncology.
Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions desired
Sitting, standing, walking, bending, ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Very limited travel requirements.
Primary interactions with GBDM (statistics, programming and data management). Will also interact with clinical, regulatory affairs, clinical operations, project management, translational oncology and diagnostics representatives.
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.
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.
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.