Pfizer Statistics Senior Manager in New York City, New York

Role Summary:

  • Maximizes value of statistics within Pfizer through strategic application of high-quality statistical approaches from discovery, clinical development, regulatory interactions, to product defense and commercial support.

  • Provides expert statistical advice and guidance to project leadership and scientists as needed, in collaboration with project statisticians, in the planning and execution of development, marketing, and lifecycle support of Pfizer products.

  • Provides statistical expertise to develop and champion techniques intended to increase understanding of drug development problems and seeks creative solutions by pursuing active research though collaborations and interactions with other experts.

  • In partnership with statistical leadership, establishes sound statistical bases for the design and analysis of studies and provides clear guidance to project teams for execution by well-trained statistical staff at all sites.

  • Keeps abreast of and influences the direction of regulatory issues through external expert groups including regulatory, industry, professional and academic organizations.

  • Serves as a resource to consult with project statisticians and statistics heads in establishing consistent global systems and processes to support planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results and support for publication activities.

  • Promotes and enhances expertise within the Pfizer statistical community.

  • Develop effective collaborations with others within non-interventional study teams, partner lines (such as, Real World Data and Analytics, Medical Affairs), and external healthcare, regulatory, industry, professional and academic organizations.

  • Collaborates effectively with other SRDC statisticians to maximize the impact globally.

Responsibilities:

  • Provides scientific guidance for statistical advice, policies, and appropriate oversight for Pfizer projects as requested by the customer groups in alignment with the SRDC Group Head.

  • Provides consultation on statistical issues to Pfizer management in Discovery, Clinical Development, Legal, and Marketing. Promotes opportunities for adding value to other groups as appropriate.

  • Participates actively as needed for key go/no decisions, key regulatory and product defense strategies, as well as Scientific and Commercialization Support to provide high-quality statistical guidance and advice.

  • Provides a strong worldwide presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.

  • Pursues high-quality business-driven statistical research and presents/publishes appropriately to influence internal and external alignment with key opinion leaders.

  • Instills and maintains a global perspective, with a focus on statistical strategy for value-added research and consultation.

  • Is available as a global resource to statistical leadership and colleagues, as needed; arranges/gives relevant seminars and short courses on statistical topics as appropriate.

  • Provide assistance to the SRDC Head and Group Heads regarding the purpose and decisions surrounding recruitment, retention, and career development of the SRDC members worldwide.

Competencies: Regulatory expertise

  • Demonstrated experience and success providing timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions; demonstrated success in supporting drug products and programs with regulatory agencies.

Scientific excellence

  • Demonstrated success/results in prior scientific management roles.

Presentation/influencing skills

  • Demonstrated platform skills; experience presenting to large scientific audiences and non-scientific populations.

Systems/technologies

  • Strong understanding of the state-of-the-art technologies to evaluate and leverage them for improved business processes.

Written and verbal communication skills

  • Demonstrated strong written and verbal communication skills.

Qualifications :

  • In general, candidates for this job would have the following levels of experience:

  • Advanced degree in statistics, biostatistics, or related field.

  • MS and over 5 years experience or equivalent.

  • Ph.D and over 3 years experience or equivalent.

  • Drug development and business experience in order to have an understanding of the processes associated with healthcare, observational study operations and outcomes research strategies.

  • Technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization. Strong links to outside statistical experts and academicians.

  • Demonstrated expertise in pharmaceutical business related statistical research, and consultation with key project leaders. At least 1 year experience in providing technical direction to multiple, highly complex projects and to project teams.

  • Technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization. Strong links to outside statistical experts and academicians.

  • Comprehension of tools for high dimensional data analyses and predictive modeling / machine learning.

  • Sound computational skills in SAS and or R.

  • The aptitude to identify, understand, and apply relevant scientific literature.

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.

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.