- 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
- 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.
Honors & Publications
- 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
- Adjunct Faculty Operations Research, University of Delaware, Newark, DE
- Adjunct Faculty of Engineering, Widener University, Chester, PA
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