Pfizer Validation Statistician in McPherson, Kansas

ROLE SUMMARY

Reporting to the Validation Section Manager, the Validation Statistician will be responsible for supporting intradepartmental customers, support development, adoption and implementation of innovative solutions through statistical analysis tools, and actively engage with Pfizer statistical community in discussion of best practices.

ROLE RESPONSIBILITIES

  • Proficient in determining robust validation sampling plans based on valid statistical methods

  • Analyze production data for establishment of process control limits

  • Provide support for production data review, statistical and trend analysis for process capability

  • Build/justify sampling plans for acceptance sampling of finished goods

  • Analyze data from Process Validation to support transition to Continued Process Verification

  • Summarize key statistical findings in validation reports that is easily understood by Pfizer colleagues

  • Provide inputs for experiments including design, controls and analysis of results

  • Provide high level data analysis support for Quality Investigations

  • Provide statistical support to and/or participate on ad-hoc and limited duration teams as needed

  • Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards

QUALIFICATIONS

Required:

  • BS or higher in Applied Statistics or Mathematics with emphasis on Statistics, or equivalent area such as Engineering Statistics, Theoretical Statistics/Mathematics.

  • 3 to 5 years of experience in statistical analysis in a technical/pharmaceutical setting

  • Familiar with ASQ/ANSI Z1.4 & Z1.9 sampling standards

Preferred:

  • MS or higher in Applied Statistics or Mathematics with emphasis on Statistics, or equivalent area such as Engineering Statistics, Theoretical Statistics/Mathematics.

  • 7+ years of experience in statistical analysis in a technical/pharmaceutical setting

  • Experience with Statistical Process Control (SPC) software

Knowledge and Experience:

  • Expertise with statistical computer applications (i.e. Minitab, SAS, JMP, Excel, etc.)

  • Demonstrates strong technical/functional knowledge

  • Critical thinking and data analysis skills

  • Demonstrates good understanding of pharmaceutical industry knowledge, cGMPs and ICH guidelines, and has a strong understanding of business operations

  • Strong written and oral communication skills coupled with leadership ability and an Own It attitude

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.

  • Eligible for Relocation Package

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