Abhishek (Abhi) Dabral Email & Phone Number

New York, NY, US

New York, New York, US

Prospective Clinical Trials incorporating Real World Evidence(RWE) PMC/PMR studiesUse of AI/LLMs for automated data cleaning(edit checks, synthetic data creation)Patient/Site identification & recruitment, Protocol OptimizationClinical Trials integrating disparate longitudinal data (molecular, pharmaco-genomics, DHT etc.)Data Science and Data standardsEHR.

Washington, DC, US

Peer review for Therapeutic Innovation & Regulatory Science (TIRS), the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles.The focus areas of the journal are as follows: Biostatistics Evidence Development Clinical Trials.

Austin, TX, US

Team Member and author- SDTM Implementation Guide Team Member- PGx(Pharmacogenomics) standardsTeam Member and SDS Liaison for SHARE Metadata Repository(Now CDISC Library) - SDTM Metadata Development/Curation. Hands on experience with Akana's Semantic Manager.Team Member- SDTM Validation Rules Sub-Team.

Brussels, Brussels, BE

Speaker/contributorAdvisor, DCT guidance GCDMP AuthoringCDS Certification Committee

Brighton, MA, US

A member of the Harvard Business Review Advisory Council, an opt-in research community of business professionals.

North Brunswick, New Jersey, US

Broadstairs, Kent, GB

PHUSE is an independent, not-for-profit organisation run by a worldwide team of volunteers. We are a global community and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers, data scientists and eClinical IT professionals. PHUSE has become the industry voice to regulatory agencies and.

Dublin, IE

• Supporting a development pipeline in the field of neuroscience and oncology (Spun-off as a new entity, Mural Oncology) as well as a diversified portfolio of marketed products focused on nervous system disorders such as.
• Collaborate with Clinical Operations, Data Management, Statistical Programming, Biostatistics, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for real-time data.
• Managing clinical vendors specific to clinical data review, metrics and dashboards, data cleaning, ad-hoc reporting, CSR publications, DSUR/IB, data surveillance.
• Develop and oversee data quality plan, Data Transfer Agreements for external data acquisition(Biomarkers, Labs, PK, eCOA, PGx and other special modalities)
• CDISC SME for various cross functional data standardization- eg. SEND Dataset review & conformance check, Global Library(CDASH implementation), Lab Lookup tables, Controlled Terminology and Unit Conversion, SDTM.
• Partner with Alkermes' IT & Analytics for clinical data lake, metadata repository and data governance, systems integration, data transfer and sharing, SCE(Stat Computing Environment) and data access and storage.

Boston, Massachusetts, US

https://www.dimesociety.org/

Thousand Oaks, CA, US

• Member of Clinical Systems and Analytics LT, responsible for leading a team for digital health data acquisition/governance/aggregation of emerging data types such as mHealth, sensor, biomarker, EHR, RWD & other routine.
• Accountable for the successful execution of data acquisition strategy across clinical program portfolio.
• Ensure a constant state of Inspection Readiness (IR) by maintaining real time trackers of all data sources and traceability in clinical data flow.
• Serve on Clinical Systems leadership team, defining new practices to use clinical technologies in order to accelerate clinical trial execution and ensure best-fit designs to align with protocol.
• Partner with IS to develop a data science strategy focusing on the curation/ingestion of varying & complex data sources, building new capabilities to bring efficiencies and automation in data storage and integrations.

North Chicago, Illinois, US

• 𝟏𝟏+ 𝒚𝒆𝒂𝒓𝒔 𝒐𝒇 𝒅𝒊𝒗𝒆𝒓𝒔𝒆 𝒆𝒙𝒑𝒆𝒓𝒊𝒆𝒏𝒄𝒆 𝒘𝒐𝒓𝒌𝒊𝒏𝒈 𝒊𝒏 𝒗𝒂𝒓𝒊𝒐𝒖𝒔 𝒃𝒖𝒔𝒊𝒏𝒆𝒔𝒔 𝒆𝒏𝒕𝒊𝒕𝒊𝒆𝒔- 𝑭𝒐𝒓𝒆𝒔𝒕 𝑳𝒂𝒃𝒔, 𝑨𝒄𝒕𝒂𝒗𝒊𝒔, 𝑨𝒍𝒍𝒆𝒓𝒈𝒂𝒏, 𝑨𝒃𝒃𝒗𝒊𝒆 across different R&D functions- Statistical Programming, Biostat, HEOR, Data Management, Research.
• Data Acquisition, Integration, Standardization & regulatory submission. Led teams(direct reports and FSP) for >10 successful NDA submissions across multiple TAs: CNS(MDD, Bipolar, Schizophrenia, AD), Aesthetics(Botox).
• Selection and procurement of technology tools to achieve end-to-end standardization & automation of analysis and reporting.
• Data aggregation, reporting & advanced analytics/data visualizations in non-routine projects - RBM Statistical Monitoring, Liver Toxicity, Data Surveillance, mHealth, RWD (TriNetx) etc.
• Implementation of CDASH(Data Acquisition & Harmonization) for global library of CRFs
• HEOR data analysis, eCOAs, exploratory/explanatory statistical analysis, analytics dashboards & visualizations for NDA/HTA submissions, evidence generation & reimbursements(eg. ICER).

Conshohocken, Pennsylvania, US

• TransCelerate BioPharma Inc. is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the.
• Clinical Data Standards - TAUG review, SHARE API and
• Risk Based Monitoring(RBM)- Data pooling and programming datasets for Statistical Monitoring Project

Paris, France, FR

• Description: As part of the Biostatistics group, worked on a safety reporting system for streamlining the production of tables for FDA(CBER) submissions. The project was a global initiative to increase the efficiency.
• Lead developer for programming macros on CDISC ADaM datasets for Unsolicited Events/Reactions (ADAE) and Solicited Reactions (ADSR).
• Requirement elicitation from CDM (clinical data management) group and statisticians for standardizing table shells for safety domains.
• Pooling and analysis of data for ISS submission of Pediacel (A pentavalent pediatric combination vaccine containing a 5 component acellular pertussis vaccine, diphtheria toxoid, tetanus toxoid, a Haemophilus influenza.

Lawrence Township, NJ, US

• Description: Part of GBS Clinical Programming for a company-wide process improvement project (EmBARC - Enhanced Biometric Analysis and Reporting Capability). Using SAS on UNIX for developing metadata driven templates.
• Developed/modified macros (Clinplus) to adapt to BMS' requirements and also to enhance the functionality of the templates.
• Part of EmBARC Operations team for deployment and maintenance.
• Developed VBA macros for word for automatic book-marking and population of safety narratives.
• Worked on integration of I-review software with SAS datasets and report generation.

Atlanta, Georgia, US

Bioinformatics research, algorithms, microarray data analysis, phylogenetic analysis etc.

Atlanta, GA, US

• Description:Developed a Machine Learning (Support Vector Machine (SVM)) based tool for clustering of epidemiological data.Responsibilities:
• Developed a support vector machine based tool for automatic biomedical literature classification of medicine abstracts for CDC’s HuGENet.
• Created C/C++ based tools to break abstracts downloaded from the efetch routine of NCBI(National Center for Biotechnology Information).
• Used various statistical methods like Z-Score and TFIDF for ranking keywords for text classification.
• Wrote PHP scripts to create a dynamic webpage for presentation of results from a MySql server.

Ansari Nagar, New Delhi, IN

Gene(ORF- Open Reading Frame) finding code developed for use in high-throughput operations. It targets genomic sequences, searching for and reporting likely protein-encoding regions.

Master Of Science (Ms), Bioinformatics- Mathematics, Computer Science And Biology

Professional Certificate In Genetics And Genomics

Digital Health Specialization, Digital Medicine

Statistics In Medicine

Professional Certificate, Data Science

Data Science

Certificate, Data Management, Statistical Programming, Data Analytics, Big Data

Certifications, Various, Management Of Technology, Fhir

Bachelor Of Information Technology, Major: Computer Science

Education record

Certificate- Gg203X: Empathy And Emotional Intelligence At Work

Data Visualization With Tableau Specialization, Analytics / Data Visualization

Certified Six Sigma Green Belt (Cssgb)

General Course On Intellectual Property

Certificate