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 to EDC- FHIR based integrationsUnstructured Data Abstraction and ProcessingInspection Readiness and audit support Flatiron's representative on various industry consortium.Prism Mentor- enterprise wide mentorship program𝖥𝗅𝖺𝗍𝗂𝗋𝗈𝗇 𝖧𝖾𝖺𝗅𝗍𝗁 𝗂𝗌 𝖺 𝗁𝖾𝖺𝗅𝗍𝗁𝗍𝖾𝖼𝗁 𝖼𝗈𝗆𝗉𝖺𝗇𝗒 𝗎𝗌𝗂𝗇𝗀 𝖽𝖺𝗍𝖺 𝖿𝗈𝗋 𝗀𝗈𝗈𝖽 𝗍𝗈 𝗉𝗈𝗐𝖾𝗋 𝗌𝗆𝖺𝗋𝗍𝖾𝗋 𝖼𝖺𝗋𝖾 𝖿𝗈𝗋 𝖾𝗏𝖾𝗋𝗒 𝗉𝖾𝗋𝗌𝗈𝗇 𝗐𝗂𝗍𝗁 𝖼𝖺𝗇𝖼𝖾𝗋, 𝖺𝗋𝗈𝗎𝗇𝖽 𝗍𝗁𝖾 𝗐𝗈𝗋𝗅𝖽. 𝖥𝗅𝖺𝗍𝗂𝗋𝗈𝗇 𝗉𝖺𝗋𝗍𝗇𝖾𝗋𝗌 𝗐𝗂𝗍𝗁 𝖼𝖺𝗇𝖼𝖾𝗋 𝖼𝖾𝗇𝗍𝖾𝗋𝗌 𝗂𝗇 𝗍𝗁𝖾 𝖴𝖲, 𝖤𝗎𝗋𝗈𝗉𝖾 𝖺𝗇𝖽 𝖠𝗌𝗂𝖺 𝗍𝗈 𝗍𝗋𝖺𝗇𝗌𝖿𝗈𝗋𝗆 𝗉𝖺𝗍𝗂𝖾𝗇𝗍𝗌' 𝗋𝖾𝖺𝗅-𝗅𝗂𝖿𝖾 𝖾𝗑𝗉𝖾𝗋𝗂𝖾𝗇𝖼𝖾𝗌 𝗂𝗇𝗍𝗈 𝗋𝖾𝖺𝗅-𝗐𝗈𝗋𝗅𝖽 𝖾𝗏𝗂𝖽𝖾𝗇𝖼𝖾 𝖺𝗇𝖽 𝖼𝗋𝖾𝖺𝗍𝖾 𝖺 𝗆𝗈𝗋𝖾 𝗆𝗈𝖽𝖾𝗋𝗇, 𝖼𝗈𝗇𝗇𝖾𝖼𝗍𝖾𝖽 𝗈𝗇𝖼𝗈𝗅𝗈𝗀𝗒 𝖾𝖼𝗈𝗌𝗒𝗌𝗍𝖾𝗆. 𝖮𝗎𝗋 𝗆𝗎𝗅𝗍𝗂𝖽𝗂𝗌𝖼𝗂𝗉𝗅𝗂𝗇𝖺𝗋𝗒 𝗍𝖾𝖺𝗆𝗌 𝗂𝗇𝖼𝗅𝗎𝖽𝖾 𝗈𝗇𝖼𝗈𝗅𝗈𝗀𝗂𝗌𝗍𝗌, 𝖽𝖺𝗍𝖺 𝗌𝖼𝗂𝖾𝗇𝗍𝗂𝗌𝗍𝗌, 𝖽𝖺𝗍𝖺 𝖺𝗇𝖺𝗅𝗒𝗌𝗍𝗌, 𝗌𝗈𝖿𝗍𝗐𝖺𝗋𝖾 𝖾𝗇𝗀𝗂𝗇𝖾𝖾𝗋𝗌, 𝗋𝖾𝗌𝖾𝖺𝗋𝖼𝗁 𝗌𝖼𝗂𝖾𝗇𝗍𝗂𝗌𝗍𝗌, 𝗉𝗋𝗈𝖽𝗎𝖼𝗍 𝖾𝗑𝗉𝖾𝗋𝗍𝗌 𝖺𝗇𝖽 𝗆𝗈𝗋𝖾. 𝖥𝗅𝖺𝗍𝗂𝗋𝗈𝗇 𝖧𝖾𝖺𝗅𝗍𝗁 𝗂𝗌 𝖺𝗇 𝗂𝗇𝖽𝖾𝗉𝖾𝗇𝖽𝖾𝗇𝗍 𝖺𝖿𝖿𝗂𝗅𝗂𝖺𝗍𝖾 𝗈𝖿 𝗍𝗁𝖾 𝖱𝗈𝖼𝗁𝖾 𝖦𝗋𝗈𝗎𝗉.

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 and Real-World Evidence Product Development and Innovation

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 standards organisations such as the FDA, EMA & CDISC.

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 addiction and schizophrenia.• 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 surveillance, exploratory data review and topline results.• 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 Automation and Quality checks etc).• 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.• Serve as an industry leader & advisor in representing Alkermes in various forums such as: SCDM- Industry representative for feedback on FDA guidance on DCTDiME- DHT and other wearable and sensor data for digital biomarkersMedidata solutions design partner for their platform workbench.Roundtable/Panels on RBM, QTL and statistical MonitoringCDISC- Standards development and implementation• Manage a staff of SMEs & Programmers (FTE, contractors & offshore FSP).

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 non-EDC data modalities (eCOA,IRT,images,labs)•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 through clinical data lake, enterprise data fabric and creation of data governance framework.

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 Informatics(IT).Positions held:𝐒𝐫 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐀𝐧𝐚𝐥𝐲𝐬𝐭 (𝟐𝟎𝟎𝟗-𝟐𝟎𝟏𝟏), 𝐅𝐨𝐫𝐞𝐬𝐭 𝐋𝐚𝐛𝐬𝐌𝐚𝐧𝐚𝐠𝐞𝐫, 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐜𝐬(𝟐𝟎𝟏𝟏-𝟐𝟎𝟏𝟐), 𝐅𝐨𝐫𝐞𝐬𝐭 𝐋𝐚𝐛𝐬𝐒𝐫. 𝐌𝐚𝐧𝐚𝐠𝐞𝐫, 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐃𝐚𝐭𝐚 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬(𝟐𝟎𝟏𝟐-𝟐𝟎𝟏𝟑), 𝐀𝐜𝐭𝐚𝐯𝐢𝐬 𝐈𝐧𝐜.𝐒𝐫 𝐌𝐚𝐧𝐚𝐠𝐞𝐫, 𝐃𝐚𝐭𝐚 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬(𝟐𝟎𝟏𝟒-𝟐𝟎𝟏𝟕), 𝐀𝐥𝐥𝐞𝐫𝐠𝐚𝐧 𝐈𝐧𝐜.𝐒𝐫 𝐌𝐚𝐧𝐚𝐠𝐞𝐫, 𝐁𝐢𝐨𝐬𝐭𝐚𝐭𝐢𝐬𝐭𝐢𝐜𝐬 𝐚𝐧𝐝 𝐇𝐄𝐎𝐑 (𝟐𝟎𝟏𝟕-𝟐𝟎𝟐𝟎), 𝐀𝐥𝐥𝐞𝐫𝐠𝐚𝐧 𝐈𝐧𝐜.𝐒𝐞𝐧𝐢𝐨𝐫 𝐌𝐚𝐧𝐚𝐠𝐞𝐫, 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬, 𝐀𝐛𝐛𝐯𝐢𝐞 (𝟐𝟎𝟐𝟎)• 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), Ophthalmology(Presbyopia, AMD) , Respiratory(COPD, Asthma), GI(IBS/CC), Anti-infectives(cSSI, CAP, UTI).•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).•Company representative in several pre-competitive industry consortia like CDISC, CPATH/CAMD,Transcelerate & part of several in-house process improvement workstreams.

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 goal of delivering more high quality medicines to patients. The Placebo and Standard of Care (PSoC) Data Sharing Initiative creates a framework for data sharing that offers the potential to reduce the patient population needed to be enrolled in a clinical trial, as it is intended to allow for the leveraging of data from previous studies. Role:𝑻𝒆𝒂𝒎 𝑳𝒆𝒂𝒅, 𝑫𝒂𝒕𝒂 𝑺𝒄𝒊𝒆𝒏𝒄𝒆 𝒂𝒏𝒅 𝑺𝒕𝒓𝒂𝒕𝒆𝒈𝒚- Lead Datacelerate strategy to create a cloud based data lake of structured/unstructured data from various data sharing workstreams and build analytics/visualization capabilities on top of data to create rich translational insights.Oversee validation & traceability of data conversion (SDTM) for 100+ studies in the repository and UAT (IQ/OQ) of the integration platform.𝑴𝒆𝒎𝒃𝒆𝒓 𝑺𝒄𝒊𝒆𝒏𝒕𝒊𝒇𝒊𝒄 𝑨𝒑𝒑𝒍𝒊𝒄𝒂𝒕𝒊𝒐𝒏𝒔 𝑻𝒆𝒂𝒎- use case prioritization & realization , engagement with health authorities (FDA/EMA), authoring a DIA paper on methods for use of historical control arms for confirmatory trialsAlso, participate in other workstreams : • 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 and accuracy of safety table production. Involved constant interaction with other sites in France and Canada.Highlights:• 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 type b conjugate vaccine and an inactivated poliomyelitis vaccine.)

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 for generating Tables and Listings for FDA submissions. Highlights:• 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 database.https://www.nature.com/scitable/topicpage/human-genomic-epidemology-hugenet-1111/• 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