Pfizer Biostatistician in Andover, Massachusetts

Role Summary

Non-clinical biostatistician to provide statistical leadership, consultation and data analysis support to biotechnology derived drug manufacturing operations by interacting closely with scientists, engineers, technicians, Quality Control/Quality Assurance and other statisticians. Ability to think critically, develop unique solutions when necessary, and communicate and write analysis approaches and conclusions clearly in technical reports is a key to be successful in this position. Positon is at Pfizer, Andover, MA.

  • Estimate analytical measurement and manufacturing process variabilities

  • Determine and recommend quality control (QC) assay limits and evaluate assay performance

  • Assess drug specification limits and process control limits

  • Determine and recommend test designs and acceptance criteria for analytical method validations, critical reagent qualifications and comparability studies

  • Provide statistical input to standard curves, reference standards and replicate sample sizes of analytical methods and bioassays

  • Perform stability analysis of drug products, and estimate stability profiles and shelf lives

  • Support investigations of deviations, and unusual and out of specification results

  • Recommend environmental monitoring limits and rules

  • Provide input to SOPs, test protocols, study reports, regulatory submissions and queries

  • Develop standard statistical approaches to common problems by collaborating with statisticians and scientists from multiple Pfizer locations

  • Author formal reports and/or make technical presentations of complex statistical concepts, conclusions and results in a format that can be easily understood by those with little or no statistical background

Basic Qualifications

  • MS required, PhD preferred in statistics, mathematics or related discipline

  • Three years working experience in chemistry, biology, engineering, analytical methods environment

  • Pharmaceutical industry experience under cGMP environment is preferred

  • Five years experience in Statistical Process Control, control chart theory, design of experiments, hypothesis testing, statistical modeling (linear and non-linear regressions, mixed models, variance components), statistical simulations, etc.

  • Familiarity with prediction, confidence and tolerance intervals, data transformations, process capability indices (Cpk, Ppk)

  • Proficiency in statistical software packages (e.g., JMP, R, MINITAB and SAS) and Microsoft Office (Excel functions, VBA, Word and PowerPoint) under Microsoft Windows environment

  • Knowledge of cGMPs, FDA/EMA and other regulatory guidelines (e.g., ICH, USP, EP) as applied to drug manufacturing

  • Experience in authoring technical reports and/or professional journal articles

Preferred Qualifications

  • Skills in generating software code to automate repetitive statistical analyses

  • Experience in leading work groups or managing personnel

  • Knowledge of acceptance sampling standards ANSI/ASQ Z1.4 and Z1.9

Work in an office environment with occasional standing, walking. Ability to perform mathematical calculations and ability to perform complex data analysis.

M-F days - 40 hours/week.

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.

Other Job Details:

Last Date to Apply for Job: November 23, 2018

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.