Pharmaceutical Bio-Statistician and Pharmacokinetics Modeling and Data Analysis

Technical Consultant #1789

Pharmaceutical 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 prostrate and NSCLC).

Undisclosed Company, Pharmacology and Biostatistics and Data Management 2009 - Present

Group Leader

Focus on specialized pharmaceutical statistics services, provided consulting for sponsors from protocol to study report.
Lead regulatory submission discussions with FDA.
Developed clinical development plans and clinical study outlines for new programs.
Lead and manage a group of biostatisticians and SAS programmers.
Projects with start-up for established pharmaceutical companies to begin working in vaccines and oncology therapeutic areas.
Designed and implemented complex Phase I/II cohort studies various oncology clinical trials. Provided consulting on clinical trial design, conduct and protocol development for oncology and vaccine trials.
Developed SAP, regulatory plans, scientific advisory prep, and clinical study reports.
Familiar with ICH guidelines for integrated summary documents for regulatory submissions.
Experience interacting with the FDA personnel on bio-statistical issues.
Highly experienced in the analysis of scale data, both investigator and patient assessments including the preparation of integrated databases and preparing ISS / ISE reports.
Collaborated and worked with experts in academia and former regulatory statisticians.

Undisclosed Company, 2007 - Present

Senior Director Biostats/Analytics Consultant

Conducted bio-statistics, exploratory and clinical data analysis and statistical data analysis projects for pharmaceutical and healthcare industries.
Prepared RFP responses for clinical drug development projects and participated actively in the bid defense to win the RFP bids successfully.
Developed and clinical development strategies from idea to proof of concept/action stages of drug development for start-up biotechnology companies.
Provided consulting on various clinical trial designs and developed study synopses/protocols for oncology clinical trials. Major client activities Include:
- Analyzed and prepared Statistical analyses for client meetings and presentations.
- Design and evaluation of clinical pharmacokinetic data.
- Design PK/PD analysis plans and perform PK/PD analyses.
- Develop clinical study reports with Clinical Pharmacology and Statistics.
- Variance and covariance modeling using SAS for the analysis of lab provider data.
- Prepared statistical analysis plans for investigator initiated and sponsored clinical trials.
- Designed and developed standard statistical analyses reports, graphs and listings.

Astra Zeneca LP, Wilmington, DE, Associate Director, 2002 - 2007

Global Clinical Information Sciences

Responsible for providing data related strategic and operational leadership to delivery teams involving up to 30 or more professionals for delivering clinical submission package.
Hands on work with bio-statistics, pharmacokinetics and data analysis for clinical trials in oncology, CV and CNS areas.
Lead a group of biostatisticians and statistical programmers to achieve corporate goals.
Lead IND and sNDA teams to deliver the submission deliverables as program manager.
Lead and provided input for protocols, study reports and IND submissions.
Performed and lead statistical design, analysis and programming support for advanced statistics.
Performed pharmacokinetic data analysis and bio-statistical analysis using SAS and S-Plus.
Worked with Phase I and II data and statistically analyzed for interim decision making.
Electronic submission for FDA submission.
Worked with the trial set-up activities and developed randomizations and statistical analysis plans.

Merck & Company, (MIS INC), West Pont, PA, Data Management and Statistics Consultant, 1998 - 2001

Primary focus was to rapidly launch the Phase IV Program to evaluate the treatment GAP in statin usage for CHF and CHD patients to grow the statin (ZOCOR%uFFFF) market share.
Worked on statistical analysis using SAS and data mining tools.
Acted as a Project Manager and a statistician between Merck and the CRO in delivering the publication data, results and reports.
Designed and developed statistical analyses to create quality reports and graphs for medical publications.
Performed preliminary data analysis to check data validity on the chart review data.
Involved in the development of chart review data tables - demographic data tables, discrepancy data tables.
Developed and validated data listings, summary tables, graphs and charts for final analyses.

Hercules Incorporated, Pharma and Device Division, Wilmington, DE, 1997 - 1998

Global Pharmaceutical Process Services Manager

Mentored and supervised oral process services and manufacturing group.
Provided analytical tools for pharmaceutical market research and business.
Developed graphical and quantitative tools for GMP manufacturing processes using SAS/ MATLAB.
Successfully translated the customer requirements into actionable decision processes.
Developed and designed statistical analysis tools for scale-up of pharmaceutical ingredient production.

Process and Analytical Technologies Manager - Pharmaceuticals, 1989 - 1996

Mentored and supervised the GMP facility personnel for formulations and medical device products group.
Built customer relationships through contributing to industry trade associations.
Managed the deliverables, budgets, and resources for the process development projects. Used statistical tools for pharmaceutical formulation stability.
Developed statistical and neural networks models for production data of pharmaceutical excipients.
Defined, developed and tracked research and development project performance, metrics and monthly reporting.
Developed methods for pharmaceutical formulations for tablet making and stability of formulations.

Credentials

Software: Microsoft Office, SAS, SQL, SPSS, Neural Networks, S-Plus, MiniTab, Matlab
Languages: Visual Basic, Visual C , C, Fortran
Clinical Software: MS Project/Access, Electronic and Web Based Data Capture (EDC and QBDC)
Project Management: MS Project, MS Access, and ACCORD (Study Finance Software)

Academic and Professional Affiliations

Publications and Patents

Over 25 Statistical Analysis/Strategy publications in various Conference Proceedings and Professional Journals.

Ph.D. Statistics and Chemical Kinetics (PK), University of Cincinnati, Cincinnati, OH
MBA Finance and International Business, University of Delaware, Newark, DE
M.S. Chemical Engineering (Kinetics), Indian Institute of Technology, Madras, India
B.S. Chemical Engineering, Osmania University, Hyderabad, India