SUMMARY:

• Over 11+ years of experience in providing strategy, design, development and management primarily in pharma industry supporting clinical research services domain.
• Expertize in Clinical Trials and related systems.
• I worked in various capacities designing and building data analysis, statistical analysis for regulatory submissions, periodic reports, risk management analysis, publications, clinical trials data integration, safety data pooling activities, data de - identification (i.e. policy 70), clinical trial registry, designing data visualization applications, managing key projects and initiatives.
• Experienced in Clinical Data Sciences, Data Standards, QA, Compliance requirements and continuous process improvement to increase productivity and reduce redundancy.
• For the past 1+ years I have been providing strategic direction to business, delivering customer centric services, setting up successful teams, developing and building capabilities of associates to raise competence levels and deliver to global customers.
• Detail-oriented and self-motivated professional with verifiable track record of consistently delivering complex projects on time and exceeding expectations.
• Consensus-driven communicator with an enthusiastic “Can-do” attitude and productive contributor in a fast paced in multi-cultural work environment.

AREAS OF EXPERTISE:

Business DevelopmentClinical Trials (All Phases)

Building Successful Teams Process Improvement

Quality and Compliance Statistical Analysis and Reporting

Project ManagementData Standardization (CDISC)

Strategic PlanningClinical Systems and Applications

SAS Programming End to End Clinical Reporting

Metadata ManagementData Governance Process

Modular SAS Macro DevelopmentData Submission Process

PROFESSIONAL EXPERIENCE:

Confidential, Titusville, New Jersey

Service Delivery Manager, Biostatistics and Statistical Programming

Responsibilities:

• Managing several therapeutic areas in Biostatistics and Statistical Programming for Big Pharma clients
• Responsible for a team of 30 associates with 4 junior managers/leads
• Developing associates and managing their career aspirations was a key objective for me
• Standardize to the extent possible on approach and process with different clients (different Big Pharma clients)
• Designed and implemented a metadata driven approach to perform data transparency activities.
• Designed, developed and implemented metadata driven modular template programs for statistical reporting.
• Managed resource planning, project management, budget management and forecasting for biostatistics and statistical programming activities.
• Driven implementation of process improvements and initiatives, with the objective of enhancing productivity and efficiency at site whilst maintaining consistent processes.
• Responsible for Budgeting, Planning, Organization, Co-ordination of all internal and external activities supporting clinical biostatistics and statistical programming for different therapeutic areas.
• Supported Business Development by participating RFI, RFP response, BID Defense for multiple global pharma clients.
• Foresee, plan and optimize Biostatistics and Statistical Programming resource utilization to cater project needs effectively.

Confidential

Principal Programmer, Research and Drug Development

Responsibilities:

• Supported multiple submission projects as a B&SS and SR SWAT expert.
• Provided guidance to project team about e2e (end to end) data flow.
• Reviewed therapeutic area specific CRF data standards adhering to CDASH standards.
• Ad Hoc consultant for all projects (Novartis) in emergent issues.
• Development of ADaM user guidelines for end users.
• Defining standard metadata for AGB approved ADaM domains as per BDS structure.
• User guidelines for Open CDISC checks and interpretations of the log.
• User guidelines for analysis parameter creation request.
• Responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, and tables) for major, complex clinical drug programs with multiple indications/projects.
• Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, DSUR, PSUR, RMP and publications within the drug development program.
• Lead in develop of project-level programming standards and ensure compliance with project-level/disease-area/company standards in conjunction with the Biometrician/Statistical Scientist.
• Supported the CSU statistician for development of disease-area programming standards, following internal/external guidelines.
• Ensured documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase III clinical trials and submission activities.
• Lead project level activities like, generation of analysis datasets, pooled datasets, listings, tables, figures, listings, and Case Report Tabulations for Phase II and III clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update (i.e. DSUR and PSUR) ).
• Supported project level publications and market promotion activities as required based on established milestones.
• Responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in MAP and CSPD) for the clinical drug projects (Autoimmunity).
• Ensured QC compliance and responsible for program records including archiving of programming and associated documentation.
• Responsible for quality control and audit readiness of quality programming deliverables for the clinical drug projects.
• As required, acting as a programmer representative on major process improvement initiatives and/or other non-clinical project activities.

Senior Programmer

Confidential

Responsibilities:

• Supported /development of new programming applications.
• Ensured QC compliance and in charged for project records including archiving of programming and associated documentation.
• Supported development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in RAP, MAP and CSPD) for the clinical drug project (ID and Hep-C).
• Developed advanced MACROs for general use of programmers (i.e. Open CDISC check run in GPS environment, RAP M8 generation, SDTM annotation and Pure SDTM and ADaM datasets generation macro).
• Contributed to SCR team and supported SCR application implementation in clinical reporting environment.
• Prepared Case Report Tabulations for the submissions as required (defoine.pdf for Non-CDISC projects and define.xml for CDSIC projects).
• Supported the full execution of final production output generation of quality, timely programming deliverables for CSRs.

Senior Programmer, Research and Drug Development

Confidential

Responsibilities:

• Supported development/update of study level programming specifications of analysis datasets (e.g. RAP) for the multiple clinical studies (ID and Hep-C).
• Supported development / Validation of analysis datasets, Tables, Listings and graphs for multiple studies in project / indication.
• Maintained QC compliance and in charged for trial records including archiving of programming and associated documents.
• Reviewed planned edit checks and assisted non-standard, complex data validation programs as needed according to agreed plans for the clinical trials in project / Indication.

Senior Statistical Analyst

Confidential

Responsibilities:

• Coordinated efficiently with internal and external customers for trail level (e.g. Program programmers, Program statisticians and clinical team).
• Supported development of analysis datasets, Tables, Listings and Graphs according to specifications (i.e. RAP M7.1 and RAP M8).
• Supported quality control and quality audit of deliverables.
• Supported and developed appropriate sections of RAP for standard clinical trials.

Confidential, New Jersey

Programmer - Clinical Research

Responsibilities:

• In charged as a lead programmer to write SAS programs that produce analysis datasets and analyses specified reports as per Statistical Analysis Plan.
• Assisted the reporting manager in overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality standards.
• Developed standardized MACROS (e.g. extraction macro to fetch the data from OC, study wise investigator list extraction from OC database, and creation of study level format catalog from OC).
• Involved in creation and review of SOPs and Departmental Work Instructions manuals.
• Involved in organize, plan, and prioritize work to develop specific goals and plans to accomplish project objectives.
• Directly interacted with clients as a lead programmer and timely delivered all requested analysis reports.

SAS Programmer

Confidential

Responsibilities:

• Supported HA requests and AD-Hoc report analysis.
• Performed data conversion of legacy data to CDISC SDTM compliance for FDA submission.
• Developed value analysis documentation (VAD) for analysis datasets as per SAP document.
• Performed review of SAS programs and SAS logs to comply with internal / external SOPs / WI.
• Mentored new joiners and junior programmers as needed.
• Coordinated with clinical team and senior statistician for various protocol analyses.
• Developed data derivation document for various protocols.
• Extracted data from Oracle Clinical (OC) using standard macros.
• Generated Listings, Tables and Graphs as per Statistical Analysis Plan across multiple therapeutic areas adhere to standard operating procedure (SOPs).
• Validated analysis datasets, Tables and Figures using standard SAS procedures.
• Supported as an administrator for DEAR (Data Extraction and Reporting Tool) tool.
• Trained programmers on use of DEAR tool in regular activities.
• Developed and maintained DEAR tool end user guidelines.