Mitch Kotler
Patient Centered Solutions
- Role
- Director of Biostatistics at ICON plc
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Mitch Kotler
Experienced Director of Biostatistics in the healthcare industry. Full managerial responsibilities for recruitment, performance review and other HR functions. Full Biostatistics support of regulatory submissions (FDA and other agencies)- eCTD modules, CDISC (SDTM and ADaM) conversions, OTC switch and bioequivalence routes. Supported proof-of-concept / pilot, claims, and pivotal studies; Therapeutic areas include neurology, smoking cessation, pain relief, allergy, weight control, oncology, and oral care. Expertise in process development / improvement and project milestone tracking. Statistical methodology in linear models, nonparametric statistics, exact testing, survival analysis, proportional hazards, TOST (for PK/BE), imputation, sensitivity analysis, logistic analysis of categorical data.
Experience
Director of Biostatistics
Jan 2019 — Present · Raleigh-Durham-Chapel Hill, NC, US
Education
SUNY Albany
Bachelor of Science (BS)
University of Massachusetts, Amherst
Doctor of Philosophy (PhD)
Skills
- Customer Insight
- Cross-Functional Team Leadership
- Clinical Development
- Life Sciences
- Consumer Products
- Dermatology
- Statistics
- Analytical Chemistry
- In Vitro
- Fmcg
- U.s. Food and Drug Administration (Fda)
- Regulatory Submissions
- Regulatory Requirements
- Clinical Trials
- Formulation
- Pharmaceutical Industry
- Sop
- Fda
- Edc
- Therapeutic Areas
- Pharmacology
- Statistical Modeling
- Gmp
- Medical Writing
- Biostatistics
- Clinical Data Management
- Validation
- 21 Cfr Part 11
- Pharmacokinetics
- Technology Transfer
- Data Management
- Sas
- CRO Management
- Pharmaceutics
- Drug Discovery
- Oncology
- Protocol
- Biotechnology
- Research and Development (R&D)
- CRO
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