Kaztronix
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Director Clinical Pharmacology Statistician
Job Description
Job Summary
Director Clinical Pharmacology Statistician (PSR) role is responsible for providing statistical consultation and perform/supervise/review statistical analysis on clinical pharmacology-oriented tasks for biologics and small molecules in the clinical pharmacokinetics group.
Summary of the Essential Functions of the Job
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Director Clinical Pharmacology Statistician (PSR) role is responsible for providing statistical consultation and perform/supervise/review statistical analysis on clinical pharmacology-oriented tasks for biologics and small molecules in the clinical pharmacokinetics group.
Summary of the Essential Functions of the Job
- Provide consultation on statistical issues in clinical pharmacology and related areas
- Work with pharmacokinetist, bioanalyst, and data manager to provide deliverables on time.
- Creation, modification, and review of data specifications;
- Perform, supervise, or review statistical analysis of PK and/or immunogenicity data such as dose proportionality, relative bioavailability, food effects, clinical drug-drug interaction, antidrug antibody (ADA) cut point determination, clinical immunogenicity calling, etc.
- Other related services involving statistical inputs such as power analysis and sample size calculations for clinical pharmacology study designs
- Ph.D. Or (M.Sc. Plus 3 years) in Statistics, Biostatistics, Biomathematics, or related fields.
- 10-15 years of related industry and/or FDA experience.
- Expert experience in biostatistics in clinical pharmacology.
- Expert experience with software packages, such as but not limited to: SAS, R.
- Extensive experience with supporting and/or contributing to regulatory submissions.
- Excellent written and verbal communication skills.
- Appropriate publication record is desirable.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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