Lead R&D Technologist - Statistical Programming

What you’ll do

• You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics

• You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE .

• You will work on designing safety data mart for cross study analysis and exploratory analysis

• You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials.

• You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration

• As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and executing technology projects.

• You will support leaders in engaging with clients to review clinical data models , determining requirements, establishing safety usecases, and delivering solutions that have significant impact.

• You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time

• You will review and author high-level user stories and develop related tasks, acceptance criteria and review test cases

• Your will work closely with project teams in creating requirement Specifications, requirement traceability metrics, user guides and other project requirement documents

• You will plan and facilitate various requirement gathering, solution meetings and artefacts

• You will work on creating process flows based on client and internal project discussions

• You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming

• You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community.

What You’ll Bring  

• Bachelor’s degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines
• Master’s degree in business analyst, Engineering or Science preferred.
• Experience working within Life Science Domain as solution architect / business analyst / data analyst is required.
• Experience of clinical data standards like CDISC (SDTM, ADaM), Safety data marts  is required
• Experience of FHIR, HL7, USDM is preferred.
• Experience of Data mapping and transformation in clinical data  using various tools like TAMR ,Oracle LSH etc
• Experience of generating SDTM, ADaM datasets as part of statistical programming  deliverables of clinical trials.
• Experience of designing clinical data models as part of SDTM, ADaM  or safety data marts for submission or exploratory analysis
• Experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration for exploratory analysis for clinical data of cross study
• Experience of working in any of Clinical trial design, data management, analytics, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR – SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR – Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is preferred.
• Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams
• Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required
• Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred.
• Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required.
• Experience in building and delivering GxP compliant solutions for large enterprise program is required.
• Exposure to programming language like R, Python and SAS is preferred.