- Entry level
- No Education
- Salary to negotiate
Non-clinical biostatistician to provide statistical consultation and data analysis support to biotechnology derived drug manufacturing operations by interacting closely with scientists, engineers, technicians 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 variability's
- Recommend quality control (QC) assay limits and evaluate assay performance
- Assess drug specification limits and process control limits
- 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
- PhD in statistics, engineering or science with 5 years of relevant work experience
- MS in statistics, engineering or science with 10 years of relevant work experience
- Basic understanding of chemistry, biology, engineering, analytical methods
- Pharmaceutical industry experience under cGMP environment is preferred
- Extensive 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
- 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
- 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.
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.
- Last Date to Apply for Job: 7.28.2019
- Eligible for Employee Referral Bonus
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
About the company
Pfizer, is an American multinational pharmaceutical corporation headquartered in New York City, New York, with its research headquarters in Groton, Connecticut. It is among the world's largest pharmaceutical companies by revenues.
Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology. Pfizer's products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin for neuropathic pain/fibromyalgia); Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil, for erectile dysfunction); and Celebrex/Celebra (celecoxib), an anti-inflammatory drug.