Senior Vice President, Statistical Programming

• Apr 2022 - Present

Responsible for managing Statistical Programming Department. Establish processes and SOPs co-ordinate off-shore/onsite programming activities.

Vice President, Statistical Programming

• Sep 2019 - Mar 2022

PHUSE India Events Officer

• Jan 2022 - Present

Responsible for leading PHUSE Single Day Events(SDE’s) in India. Part of PHUSE APAC Leadership Team.

PHUSE India Membership Officer

• Apr 2018 - Dec 2021

Part of PHUSE APAC Leadership Team and supporting as PHUSE India Membership Officer

CDISC Volunteer

• Apr 2020 - Present

Support development and maintenance of CDISC standards Support development and maintenance of CDISC standards

Associate Director, Statistical Programming

• Dec 2017 - Aug 2019

Responsible for managing Statistical Programming Department. Responsible for managing Statistical Programming Department.

Senior Manager of Programming, Biostatistics and Programming at PPD

• Apr 2017 - Nov 2017

Senior management position over programming managers and programming staff within the Department of Biostatistics. Coordinates the development and implementation of Standard Operating Procedures and Working Practice Documents. Interacts extensively with a multi-disciplinary senior management team to identify critical needs and develop strategic initiatives. Responsible for hiring, training, mentoring and resourcing staff. Tracks project timelines, budgets, and resource needs across Biostatistics and Data Management. Effectively communicates priorities and work direction to complete assigned tasks on time and within budget. Assists Data Management and Biostatistics with developing tools and techniques for improving process efficiencies. Show less

Manager of Programming, Biostatistics

• Aug 2014 - Mar 2017

Supervisory and management position governing functions of the programming staff within theDepartment of Biostatistics. Responsible for hiring, training, mentoring and resourcing staff. Tracksproject timelines, budgets, and resource needs across Biostatistics and Data Management. Effectivelycommunicates priorities and work direction to complete assigned tasks on time and within budget.Assists Data Management and Biostatistics with developing tools and techniques for improving processefficiencies. Show less

Associate Manager, Statistical Programming & SDTM SME

• Oct 2011 - Jul 2014

Manage and oversee team activities including appropriate resourcing of staff, staff assignments, and quality control of project deliverables and timely delivery of project deliverables.Monitor performance close interaction with PL/GRO LeadTrain, mentor and allocate team members according to their abilityProvide technical support to team members to ensure that they have the required knowledge to fulfill their duties.Check quality of team deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action.Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated teamMaintain an agreed level of productivity/billability and staff turnover.Participate in and contribute to Project bids, including client presentations.Meet client and business needs to have all projects optimally resourced with suitably experienced staff.Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan.Produce accurate resourcing plans in conjunction with the appropriate Project Team Members.Provide consultation, facilitate metrics collection and develop action plans in conjunction withManagement/Project Leadership/Leads to keep project on time and within budget.Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectivesMaintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner Show less

Principal Clinial Database Programmer & SDTM SME

• Oct 2011 - Oct 2013

The Principal Clinical Database Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Clinical Database Programmer can fill the Database Primary role on projects; liaise with sponsors, Data Operations Leaders and other functional areas as required.Further, the Principal Clinical Database Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.There are two specific functions that may be filled by the Principal Clinical Database Programmer, dependent on skill sets and experience; Clinical Systems and Support Programmer and Database Programmer. Show less

Clinical Data Modelling (SDTM) & GLIB Impl'n in Oracle Clinical, Senior eCRF Developer

• Sep 2010 - Sep 2011

Develop and maintain trial specific database applications, including eCRFs, validations programming, monitoring reports and database specifications in support of in-house and outsourced trials globally, of moderate complexity, for Phase I-IV studies.To support development of “Novartis clinical data standards” as per FDA SDTM submission requirements• Perform Data Modeling (OC & SDTM annotation) of CRF Pages.• To develop & maintain Metadata for each SDTM Domain• To Setup all Global Standards Objects (DVGs, Questions, QG’s, DCM’s & DCI’s) in Oracle Clinical for usage by Database programmers at study level. Show less

Clinical Data Modelling (SDTM) & GLIB Impl'n in Oracle Clinical, eCRF Developer II

• Jun 2009 - Aug 2010

eCRF Developer I

• Oct 2007 - May 2009

TableTrans Programmer (SDTM Mapping)

• Mar 2007 - Sep 2007

Job profile includes mapping Clinical Data from Clinical Database to CDISC SDTM 3.1.1 format to submit to FDA using SQL/PLSQL Oracle skills.Generate SDTM Views of Clinical Data entered in eCRF’s to submit the data to FDA in appropriate format using CDISC Submission Data Standards.

Inform Study Builder

• Oct 2006 - Feb 2007

Develop electronic clinical data management (eCDM) systems (eCRFs, edit checks, visit structures, workflows, system settings, role assignments, etc) using INFORM software tool.

Scientist

• Sep 2005 - Oct 2006

Job profile included building biomolecular interaction database such as PathArt: PathArt is a comprehensive collection of manually curated information from literature as well as public domain databases on more than 1000 signaling and metabolic pathways. PathArt is an invaluable tool for analysis and biological interpretation of microarray data onto pathways. PathArt also provides a collection of 50000 components across 21 high priority disease states and 10 different physiologies with emphasis on pathway responsive genes, mutations and knockouts.Druggable target module includes all the PK, PD values and links to publicly available drug information resources for each of the disease targets in PathArt.Interaction-Map module provides information for 150,000 protein-protein & small molecule-protein interactions. Show less

Associate Scientist

• Sep 2004 - Sep 2005

Job profile included building biomolecular interaction database such as PathArt: PathArt is a comprehensive collection of manually curated information from literature as well as public domain databases on more than 1000 signaling and metabolic pathways. PathArt is an invaluable tool for analysis and biological interpretation of microarray data onto pathways. PathArt also provides a collection of 50000 components across 21 high priority disease states and 10 different physiologies with emphasis on pathway responsive genes, mutations and knockouts.Druggable target module includes all the PK, PD values and links to publicly available drug information resources for each of the disease targets in PathArt.Interaction-Map module provides information for 150,000 protein-protein & small molecule-protein interactions Show less