Experienced biostatistican to support pharmaceutical data analysis in drug development, efficacy screening and clinical trials.Statistical AnalysisProtocol Development - Pharmaceutical, Biotech, Medical Device, NIHPharmacokinetic (PK) AnalysisSAS ProgrammingStatistical Report WritingData and Safety Monitory BoardSensitivity Analysis2002 - Present Independent ConsultantStatistical services to the pharmaceutical, biotech, and medical device industries and the National Institute of Health (NIH).Statistical services...

FDA Regulatory Statistician Experienced in all phases of Clinical Trial Design, Analysis, and BiostatisticsBiostatistics: Regulation of drugs, drug devices and biologics.Clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.Expert regulatory statistician (FDA designation).Areas of application include clinical trial design and analysis, interim analyses, multiple imputation, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity stud...

Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

Statistical Sampling and Experiment Design Chemical Engineer with Expertise in Yield Improvement, Process Optimization, and Quality Control for Healthcare and BiotechnologyStatistical consulting for specialty chemicals, health care, biotech and quick-service restaurant businesses.Solving process and product development problems and implementing quality assurance tools to increase yield, reduce costs, speed new product introductions and improve profitability.Application of statistical methodology and design of experiments (DOE) to product and process development, manufacturing cost and yield improvement, process validation, process optimiza...

Ph.D. Consultant with expertise in Characterization and Quantitation of Proteins and Small Molecules. Subject Matter Expert (SME), Oversight (in-house-external) CRO support, and GLP/GMP.Analytical and bioanalytical methods for characterization and quantitation of drug therapeutics and pharmaceutical product development.Monitor analytical and bioanalytical activities at CROs in support of non-clinical and clinical trials.Characterization of small molecule, biologics (peptides, proteins, and antibodies), antibody drugs conjugates (ADCs), PEGylated proteins, and oligonucleotides.Drug Metabolism and Pharmacokinetics (DMP) parameters, basic no...

Expert in applied statistics, biostatistics and mathematics - designs analyses for clinical trials, pharmaceutical exposure and efficacy, Medicare/Medicaid effectiveness and learning methodologiesClinical trials protocols, statistical analysis plan and clinical study reports.Bayesian inferential and decision analysis.Integrated Analyses of Efficacy and Safety.Due diligence.Pharmaceutical adaptive designs: blinded and un-blinded sample size adjustment, group sequential designs.Clinical trials sample size determination.Mixed models repeated measures models.Pharmaceutical product exposure modeling.Statistical programming in SAS (MACROs, IML,...

Pharmaceutical Statistics Data Analysis and Clinical Trial DesignPharmaceutical bio-statistician.Pharmacokinetics and data analysis for clinical trials.CNS: Schizophrenia, bipolar disorder, Alzheimer's disease, migraine and over-active bladder.CV: Hyperlipidemia, diabetes (novel PPAR y & %u0105, atrial fibrillation, anti-platelet agent.Oncology: VEGFR EGFR inhibitors, lung and thyroid cancer, non-small cell lung cancer, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), advanced solid tumors.Immunology: Malignant melanoma (DNA immunotherapy, hepatitis B and C (PEG-Inetrferon), H5N1 vaccine, RNAactive-derived vaccine (for p...