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JOB SUMMARYSummarize the primary purpose & key accountabilities of the job.Primary responsible for liaising with Clinical Development project team members, and specifically with the Clinical Pharmacology Lead, to contribute to clinical study protocols, statistical analysis plans, reporting plans, and delivery of non-compartmental analyses (NCA) and contributions to the Clinical Study Report for Clinical Pharmacology studies.
May help provide support and/or development of quantitative methodology and best practices, pharmacometrics tools, software, hardware, and related business processes.
JOB RESPONSIBILITIESIndicate the primary responsibilities critical to the job.Responsible for the planning and execution of relevant pharmacokinetic, primarily but not limited to, non-compartmental analyses (NCA) which may include pharmacokinetics and pharmacodynamics studies in collaboration with partners.
Prepares interpretation, preparation, and review of pharmacokinetic contribution to clinical and written study reports to Pfizer standards.
May provide Quantitative Clinical Pharmacology expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians and statisticians to to provide pharmacokinetic analyses.
May contribute with project teams/partners to investigators brochures, clinical pharmacology summaries, manuscripts, and regulatory documents.
Stays abreast of literature, government guidelines, and internal guidance as relates to pharmacokinetic analysis, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications.
May contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
QUALIFICATIONS/SKILLSIndicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.Basic Qualifications:B.S. with 2-4 years of experience in quantitative data analysis, or M.S. with 0-2 years of experience in quantitative data analysis
Experience using WinNonLin, Phoenix, Kinetica, or equivalent
Good communication skills (written, oral presentation)
Preferred Qualifications:Other statistical software experience (e.g. R)
Other relevant software experience (e.g. Microsoft Excel and Word)
We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc.
ORGANIZATIONAL RELATIONSHIPSProvide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical Pharmacology.
Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required.
PHYSICAL/MENTAL REQUIREMENTSN/ANON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSN/ARelocation support availableEligible for Relocation Package: NOEligible for Employee Referral Bonus: YES#LI-PFESunshine ActPfizer 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 EligibilityPfizer 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.Medical
