Document Sample
Objective Powered By Docstoc
					Curriculum Vitae                                                                   Pitman, A.
                                        Arkadiy Pitman
                                        3 Granite Road Ext,
                                        Peabody, MA 01960
                                          (978) 530-2112,

OBJECTIVE: Provide for scientifically rigorous program of advanced statistical programming
and research utilizing a system of principles derived from a broad base of hands-on
pharmaceutical and healthcare experience and strong background in mathematics, statistics and
logistics. Establish and/or support cross-functional coordination of data flow process:
identification and cost-effective resolution of program deficiencies predicated on detailed
knowledge and deep understanding of all related functional areas.
Main Fields of Expertise:
Biostatistics; Data Management; Health Quality, Outcomes and Economic research;
Coordination of Data Management and Biostatistics activities with other departments;
Organization and management of cross-functional „CRO-„ and „in house-„ based teams; Design,
organization and reporting in clinical (including adaptive) trials; Database design; Statistical and
clinical programming; Regulatory submissions; Benefit-Risk Analysis; Organization of panels
and blinded medical reviews; Scoring in outcome assessment; Probability Theory and Statistics;
Mathematics; Mathematical and Statistical Modeling.

                            Summary of Expertise and Experience:

   Biostatistics: Design of health outcome and health services observational studies; Sampling;
    Sample size calculations; Design of clinical trials including adaptive trials, Statistical
    Analyses Plans; Interim analyses; Data reporting and presentation for study reports;
    Integrated safety and efficacy; Ad Hoc and advanced statistical research (meta-, Bayesian,
    survival and regression analyses)
   Data Management: Design and construction of analytical databases from various sources;
    Design of data collection, CRF, edit checks and database for multi-site clinical trials; Data
    cleaning and data validation (program design, management and reporting) with emphasis on
    safety and laboratory data
   Management: Line management responsibilities for assigned staff; Integration of all data
    related activities into a reliable, cost- and time-effective data flow process; Collaboration
    with multiple CROs on multiple projects and ongoing clinical trials; Management and
    supervision of CRO- and/or in house- based specialized cross-functional teams
    (programmers, statisticians, data managers, monitors etc.) of different sizes (up to 20) for
    different periods of time (from weeks to years); Budgeting and coordination of all
    Biostatistics and Data Management activities; Interaction with senior management on all
    related issues; Communications with leading scientists and principal investigators;
    Combining efforts with Sponsors; Organization of DSMB, medical panels and reviews
   Regulatory: FDA (BLA and multiple INDs) and EMEA/MHRA submissions and marketing
    application (MAA) under ICH requirements; Dialog with Regulatory agencies including
    scientific presentations, formal meetings and Advisory Committee meetings
Version10                                Page 1 of 4
Curriculum Vitae                                                                Pitman, A.
   Programming: Highest level of proficiency with SAS (certified Advanced SAS
    programmer) including production programming; Hands-on knowledge of major statistical
    software (S-PLUS, MATLAB, PASS, R, etc.). Languages: VB, C/C++, PL/SQL; Macro
    programming in Excel;
   Databases: Design and programming (SAS, Oracle, MS Access); Experienced in work with
    large mainframe databases (Veteran Administration, Healthcare, Health services, Health
    insurance); Expertise in SAS- and Oracle- oriented clinical databases (ClinPlus, ClinAccess,
    ClinTrial); Support of CDISC
   Medical Science: ICD9, MedDRA, COSTART, WHO Drug – coding; Assessment of safety
    and efficacy, support for DSMB; Pre-hospital /in-hospital trauma and surgical settings,
    oncology and cardiovascular trials, special expertise in anemia treatment and transfusion
    practice principles
   Mathematics and Statistics: Broad experience in the application of mathematical
    principles and advanced statistical methods in clinical and basic science with emphasis on
   Teaching and Mentoring: Training and mentoring of assigned staff; Statistical/Clinical and
    database programming; Statistics, Mathematics, Logic (formal logic and logic in problem
    solving), Computer Science (logic and algorithms)
   Publications and Presentations: Outcome research; Study Reports; SAS programming;
    Meta analysis; Data cleaning; Logistic modeling; Modeling of hemoglobin concentration;
    Safety vs. Efficacy; Scoring in benefit-risk assessment.

                       Summary of US Experience (1998 to present):

December 2008-present Ariadne (Therapeutics Development Sciences), Boston, MA
 Evaluation and optimization of clinical development programs
 Development of Safety-oriented Cost-effective Quantitative approach to Benefit-Risk
   Assessment (
Other ongoing projects/contracts
 Mathematical model of software development: Estimates, Risks evaluations, Statistically
   based predictions for major IT projects (ExigenGroup, NYC)
 Creation of long-term development program for university-based CRO: Organizational,
   financial and scientific aspects for business expansion (Confidential)

September 2001-November 2008        Biopure Corp, Cambridge, MA
         o Senior SAS programmer/analyst (2001-2002)
         o Manager of Statistical Programming (2002-2003)
         o Associated Director, SAS programming (2003-2004)
         o Director of Data Management (2004-2005)
         o Director of Biostatistics and Data Management (2005-2008)

Everyday Responsibilities:
    All aspects of staff management including hiring, performance evaluation, discipline,
      mentorship and training for Biostatistics and Data Management departments

Version10                              Page 2 of 4
Curriculum Vitae                                                                      Pitman, A.
       Interaction with senior management and active participation and support of company
        strategy and the executive decision making
       Coordination of CRO-based and in-house activities with limited budget: Distribution of
        work load, CRO selection/negotiation and supervision, leadership for cross-functional
        project-based teams, QC of project deliverables
       Budgeting of DM, Biostatistics and Statistical Programming activities with emphasis on
        cost- and time- effectiveness
       Participation in general planning for new clinical trials and development of clinical
        programs, collaboration with other departments, clinicians and medical experts;
       Management and supervision of study protocols, SAP, database design, CRF, data
        collection and data validation for ongoing clinical trials
       Interpretation of results, planning of additional statistical analyses, management and
        supervision of results presentation (tables, graphs, listings, figures), participation in study
        reports creation for completed clinical trials
       Supervision of SAS software
       Participation in scientific publications and presentations

Major Regulatory, Biostatistics and Data Management Projects:
   Participation in BLA submission as Manager of Statistical Programming (2002)
   Evaluation of biostatistics and data management questions (data integrity and safety
     assessment) in clinical hold letter from FDA and development of response strategy
   Inventory and re-structuring of legacy data (2002-2003)
   Review and validation of major study reports from BLA, including amendments to
   Creation of system of SOP for Biostatistics and Data Management Department (2002-
   Data cleaning of phase III pivotal study with emphasis on Safety (assessment of residual
     error) and Laboratory databases (Re-creation of entire database with full source
     verification of 38-sites study, which was performed in US, UK and SA with data
     reporting for >100 lab tests, collected at 10-20 time points, from both Local and Central
     Laboratories) (2002-2004); Note: Execution phase of the project was based on
     streamlined data flow and 100% accountability and was performed in house 3 times
     faster and under fraction (8-10% ) of budget from original CRO proposal
   Successful defense of data and database integrity with FDA (2005)
   Re-analyses and re-evaluation of results of major phase III pivotal study with sub
     sequential submission of Safety Response to FDA (2004-2005)
   Integration of all data related activities routed in different departments and CROs into a
     viable (reliable, cost- and time- effective) data flow process (2005-2007)
   Preparation for BPAC (Advisory Committee) on planned phase III trauma trial (2006)
   Re-submission of application for approval to MHRA with change of label (2007)

Major Scientific Projects: (in collaboration)
   Modeling of concentrations of hemoglobin (Hb), Plasma Hb and hematocrit (Hct) for
      different types of transfusions and development of dosing software for physicians
   Recommendations for amendment of clinical development program based on meta-
      analysis of safety data for multiple oxygen carriers
   Development of subgroup analyses for cross-over non-symmetrically designed anemia
      trials, based on patient clinical needs
Version10                                 Page 3 of 4
Curriculum Vitae                                                                 Pitman, A.
       Study of transfusion practice for anemia treatment with emphasis on transfusion triggers
       Creation of Outcome Scoring System (OSS) for non-biased cost- and time- effective
        evaluation of safety in clinical trials
       Application of OSS for benefit-risk assessment of planned trial

May 1999- September 2001 Boston University/Veterans Administration, Bedford, MA
           Center for Health Quality, Outcomes and Economic Research
           Senior SAS programmer/analyst/statistician

Major project: (Supported by a 3-year grant from the VA)
     Work with large mainframe VA databases as well as with other sources, performed data
     validation and data cleaning; database design for future statistical research; advanced
     statistical analysis (covariates selection, Bayesian analyses, regression models,
     bootstrapping); reporting results for numerous publications and presentations;
     development of project-related Macro programs packages.

1998-present Consulting and Teaching
    Statistical analyses of various medical data: design, modeling, reporting
    Observational studies: design, statistical analyses
    CRO-based project supervision: Organization of data flow, Coordination of different
      activities, Start-up consulting
    Preparation of manuscripts as a continuation of work for BU/VA
    Courses: “Statistical Programming in SAS”, “Advanced Macro Programming”, “SAS
      Programming for Clinical Trials”

                        Summary of Non-US Experience (1978-1997):

Teaching: Taught courses in Mathematics, Logic, Computer Science, and Statistics within
colleges and the University at Kharkov, Soviet Union.
Courses: “Programming in C and C++”, “Computer logic and algorithms”, “Database design”,
“Probability theory and statistics”, “Mathematical Logic”, “Mathematical Analysis and
Calculus”, “Linear Algebra”, “Analytic Geometry”, “Modern science in mathematical teaching”
Consulting work: Database design and Statistical analyses for marketing and manufacturing for
chemical plants
Management: Vice Principal in Computer College, Project leader in organization/set-up of data
collection and data analysis programs

Formal Education: Kharkov State University, Kharkov, Ukraine, Soviet Union
   Faculty of Mathematics and Mechanics Master of Science in Mathematics, Graduated with
   Honors, Qualification: Mathematician, Lecturer of Mathematics (colleges and universities)
Personal:     Born December 19, 1957, married, one child, emigrated from Ukraine in 1997 as
              refugee, was granted US citizenship in 2004.
Lifetime professional interest:
       Problem solving in multi-disciplinary environment: Theory and practical applications

Publications / Presentations / Workshops / Course notes: Available upon request
References: Available upon request

Version10                               Page 4 of 4