SUMMARY

• NDA/BLA Submissions, Biostatistics, Design and Reporting of Clinical Trials Phases I - IV. Statistical Analysis Plan (SAP) Preparation, Programming Specifications, and Tables. Listings and Figures (TLFs) quality review using SAS (PC, Windows and UNIX environments), CDISC (SDTM and ADAM Models).Clinical Study Reports (CSRs) preparation.
• Experience working with statistical methodologies used in clinical research.
• Excellent communication skills, both verbal and written.
• Experience working with SAS software and programming methods.
• Understanding of clinical trial reporting process and regulatory reporting requirements.
• Familiarity with data management processes for clinical trial databases.
• Experience working with CDISC data standards.
• Well developed technical writing skills.
• Proficient computer skills including experience working with Microsoft Office.
• Ability to handle multiple projects with short, changing, and often conflicting priorities.
• Team player.

PROFESSIONAL EXPERIENCE

Confidential

Lead Biostatistician/Sr. Statistician

Responsibilities:

• Provided in-depth statistical expertise in the areas of experiment, protocol, case report form design, database structure, and analysis plans.
• Reviewed study protocols, authored statistical sections of protocols, and developed statistical and statistical analysis plans.
• Also contributed to the decision for optimal study design and contributed to the proper use of statistical methodologies for the studies.
• Contributed to development and review of clinical study reports.

Confidential

Sr. Biostatistician (Consultant)

Responsibilities:

• Partnered with Senior Scientists, contributed to clinical development projects, including study design and implementation topics, data analyses and CSR preparation.
• Reviewed study protocols, authored statistical sections of protocols, prepared the study randomization, and developed the statistical and data analysis plans.
• Reviewed case report forms to ensure protocol objectives are met and project standards are maintained. Developed statistical programs necessary to perform analyses, reviewed and approved analyses produced by statistical programming.
• Authored clinical study reports, provided input into global health authority documents and regulatory responses for health authority submissions.
• Contributed to study publications and presentations such as for EASL, the European Association for the Study of the Liver.

Confidential

Contract Statistician

Responsibilities:

• Provided statistical support to BioMarin drug development project teams through actively providing statistical input in protocol development, study design, sample size justification, safety/efficacy analysis methods, developing statistical analysis plans, programming specifications, TLGs review and in preparing clinical study reports (CSRs).

Confidential

Contract Statistician

Responsibilities:

• Participate in the interdisciplinary review of oncology clinical trial data to ensure suitability for analysis and inference.
• Oversee development and production of tables, listings and figures performed by Confidential (CROs) to ensure accuracy and compliance with the statistical analysis plan (SAP).
• Evaluate statistical summaries and contribute to the interpretation of study result for the purpose of preparing clinical study reports.
• Experience in solid-tumor oncology, participating in data review, and CRO oversight.

Confidential

Senior Statistician

Responsibilities:

• Responsible for the statistical input provided by the group to all major documents, including clinical development plans, protocols, statistical analysis plans, clinical study reports, and summaries of clinical safety and efficacy.
• Serves as an advisor for technical issues associated with the design, performance, and analysis of clinical trials.
• Works closely with management to ensure a coordinated approach to statistical work.
• Maintains comprehensive knowledge of theoretical and applied statistics and regulatory guidelines regarding clinical trial analysis and reporting. Applies new statistical procedures as appropriate.
• Consult with client regarding statistical programming aspects (e.g., database and table design, programming, and reporting specification) of clinical trial investigations (e.g., Clinical Study Report (CSR), submission documents, regulatory responses, abstracts, manuscripts, and presentations).

Confidential

Consultant Statistician

Responsibilities:

• Validation of main efficacy endpoints for clinical studies
• Answer questions from Health Agencies on reported study analyses
• Interact with CRO doing the data management
• Creation and Validation of analysis datasets, and other SAS outputs for integrated safety summary and briefing book report

Confidential

Associate Director Biostatistics

Responsibilities:

• Provision of expert statistical input to protocols, analysis plans and statistical/clinical reports
• Programming of statistical analyses in SAS and other commercially available statistical packages
• Review of statistical deliverables
• To provide expert statistical input and consultancy to clinical trials and clinical development projects including design of clinical trials, specification and production of analysis and reporting deliverables (including integrated summaries) on behalf of and/or in conjunction with clients.
• Provision of expert statistical input to protocols, analysis plans and statistical/clinical reports

Confidential

Contract Statistician

Responsibilities:

• Assisted Clients in streamlining and optimizing the reporting for an FDA submission.
• Reduced turnaround time.
• Developed statistical analysis plans for Client’s Phase I Clinical Trials and revised the output: Derived datasets, Tables, Listings, and Figures.

Confidential

Contract Statistician

Responsibilities:

• Provided in-depth statistical expertise in the areas of experiment, protocol, case report form design, data base structure, and analysis plan;
• Collaborated with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity.
• Also contributed to the decision for optimal study design and contributed to the proper use of statistical methodologies for submission studies.
• Provided development and validation of derived SAS datasets and submission tabulations using SAS in Abbott’s UNIX environment.

Confidential

Contract Statistician

Responsibilities:

• Developed project statistical analysis plans (SAPs), including table specifications, statistical analyses and report formats.
• Verified statistical programs, statistical results, and data sets used in the statistical section of technical documents related to the clinical trials.
• Developed project statistical analysis plans (SAPs), including statistical analysis plan and statistical methods appendix of clinical study reports (CSRs).
• Reviewed project progress and prepared project status reports;
• Investigated, promoted and implemented new statistical concepts and methodologies to ensure utilization of ‘best practices’ and ‘state of the art’ applications in clinical research in the Respiratory area.

Confidential

Contract Statistician

Responsibilities:

• Responsible for all statistical aspects of assigned individual clinical trials in Dermatology and Respiratory areas.
• Responsible for all statistical tasks on the assigned clinical trials, e.g., clinical trial design/planning, analysis plan, reporting activities, exploratory analyses and additional analyses to support publications, and statistical consultation during the running phase.
• Tracked clinical trial activities and milestones.
• Ensured timeliness and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials.
• Followed processes and adhered to Novartis and project specific standards as well as Health Authority requirements: SOPs, Master Analysis Plan, GCP, and regulatory guidelines.
• Established and maintained sound working relationships and effective communication within the clinical trial team and the B&SR team.
• Participated in non-clinical project activities as well as
• SAS programming as needed.

Confidential

Senior Biostatistician Consultant

Responsibilities:

• Responsible for Clinical study planning, protocol preparation and review, sample size calculations using NCSS PASS and n-Query based on SBAs (Summary Basis for Approval), Clinical Research Form (CRF) and Data Management Plan (DMP) review and sign-off, Statistical Analysis Plan (SAP) preparation, hands-on data review and statistical analysis using SAS and SAS exact software.
• Statistical support to Clinical and Medical Writer project teams in Clinical Study Reports (CSRs) preparation, New Drug Application (NDA) submissions and review by the Food and Drug Administration (FDA).

Confidential

Senior Biostatistician

Responsibilities:

• Performed complex statistical and epidemiological research and development activities for a broad range of projects including clinical trials, epidemiological, health economics and outcome studies by performing the following duties personally and/or through Clinical Data Sciences Department (CDS) personnel:
• To oversee all statistical analyses of clinical data from Phase I-IV clinical trials and other clinical research studies (Cardiovascular, ECG, ECHO data), to ensure appropriateness of analytic strategies for epidemiological studies (EPI1, EPI2 and Long term follow-up)
• To manage all CDS project timelines, budgets and allocation of resources.
• To maintain regular contact with physician investigators as well as interfacing with multidisciplinary Gentiae staff as well as industry staff, marketing regulatory affairs personnel, and project managers.
• To provide consultation, in-services and updates to CDS group staff regarding methodological innovations and developments in the fields of Statistics, Biostatistics, Epidemiology, and Analysis Software Development.
• To collaborate with physicians and sponsors as the primary Biostatistician in clinical trials, manuscripts and study design problems
• To identify potential growth areas for the CDS group and to facilitate the group’s evolution.
• To manage subordinate supervisors who supervised the Data Specialists and Data Entry Technicians.
• Responsibilities also included participating in interviewing, hiring and training data managers, SAS programmers, and statisticians; planning, assigning, and directing the work of data managers, SAS programmers and consultant statisticians; appraising performance; and reviewing deliverables. Prepared clinical-statistical reports consisting of tables, listings and figures, using SAS Programming, of Safety Data (ECG) for Sponsor’s Clinical Trial submissions.

Confidential

Principal Statistician

Responsibilities:

• Prepared statistical analysis plans; communicated with clinical trial managers and CRA regarding statistical analysis issues.
• Interpreted analyses and wrote statistical sections of study reports for US, European and Japanese submissions.
• Prepared statistical reports consisting of tables, listings and figures using SAS Programming for Cardiovascular Clinical Trials.

Confidential

Biostatistician

Responsibilities:

• Provided statistical and data management support.
• Worked with medical monitors and clinical research associates at all stages in the design, analysis and report generation of clinical trials.
• Provided statistical consulting services to Medical Device and Pharmaceutical companies.
• Duties included manage statistical programming group, statistical strategy planning, data analysis, and report writing.
• Hired and provided training to contract SAS analyst/programmers to support research projects in cardiovascular and cancer research areas.

Confidential

SAS Consultant

Responsibilities:

• Prepared analysis plans and wrote detailed specifications for analysis files, consistency checks, tables, and figures; communicated with clients regarding statistical analysis issues.
• Interpreted analyses and wrote statistical sections of study reports
• Prepared edit checks and statistical reports consisting of tables, listings and figures using SAS
• Programming in Study Phases I - III including ISS, IND and NDA applications to the FDA.

Confidential

Research Analyst

Responsibilities:

• Prepared special statistical reports consisting of tables and figures for the Chairman of the Corporation and Director of Scientific Affairs, to be presented to scientific community
• Responsible for weekly and monthly statistical reports which included tables, listing and charts, to be distributed to Executive Directors in North America, Europe, Australia, Japan, Latin America and rest of the World.
• Used Excel, Access, Visual Basic, SAS, and Clintrial to actualize and extract data from Oracle Cardiovascular database.

Confidential

Contract Biostatistician/Consultant

Responsibilities:

• Participated in Clinical Protocol development of phase II clinical trial of Lutetium Texaphyrin Injection in the photodynamic treatment of patients with cancer (CNS and other types) accessible to external light illumination: Performed Sample Size Calculations using NCSS-PASS software.
• Performed Analysis Plan Preparation using Texpad and Software development for discrepancy checks based on specification sheets using SAS and ClinSAS programs.
• Participated in Protocol development of phase I/II clinical trial of Gd-Tex and Software development of Laboratory Data Summaries using SAS and ClinSAS programs based on data obtained “on line” from remote sites and their graphical representation using Excel.

Confidential

Contract Statistician/Consultant

Responsibilities:

• Responsible for statistical analysis to support NDA application to the Federal Food and Drug Administration using SAS.
• Functions include development of an analysis plan for an interim Doxil Study report on the efficiency and safety of study drug on all refractory patients including preparation of required listings, tables and figures using SAS. This was an open trial of Doxil injection in the treatment of moderate to severe AIDS related Kaposi’s sarcoma.
• Performed a matched control analysis using historical control data set and developed multivariate prognostic models for predicting response to Amphocil therapy time to specified adverse events and survival using SAS.

Confidential

Biostatistician

Responsibilities:

• Responsible for performing statistical analysis and survival analysis of breast cancer data using multivariate prognostic statistical models coded in SAS.
• Performed statistical and quantitative health risk analyses on medical topics utilizing computerized analytic tools to develop risk assessments.
• Applied statistical research techniques for critical evaluation of epidemiological literature.
• Designed and managed research databases to perform statistical analyses utilizing computer-based statistical methods, (Sigmaplot, PC SAS, and Egret).

Confidential

Senior Statistician

Responsibilities:

• Coordinated statistical processing and database in computer centre including vital statistics and epidemiological data (Cancer, Cardiovascular and Infectious diseases among others).
• Improved the quality and timing of statistical reports through a validation program based on ICD-9.
• Responsible for overview of statistical systems from data including collection, coding, analysis and National Vital Statistics year book publication.