Pharmaceutical Bio-Statistician and Pharmacokinetics Modeling and Data Analysis

Technical Consultant #1789


Expertise

  • 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).

Experience

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.

Honors & Publications

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

  • 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.

Education

  • 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
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