SAS
RAJENDRA BABU BOLINENI
Hyderabad,Telangana
Summary
Collaborative Project Lead with 12 years of experience working closely with Project Managers and other technical team members to provide support on Planning, Risk identification, Project Schedules. Adept tracking and monitoring project schedules and ensuring that delivery deadlines are met. Excellent verbal and written communication skills; able to deliver top-notch client interface and support while working effectively with members in a small team environment.
Overview
13
13
years of professional experience
4
4
years of post-secondary education
Work History
Asociate General Manager- Clinical Data Services
Clinical Data, Accenture Solutions Pvt Ltd
Benguluru
02.2020 - 08.2024
- Develops unambiguous and robust programming specifications (e.g., SDTM, ADaM specifications)
- Expert in estimation and metrics; efficiently used metrics to bring change in process for better quality of delivery
- Have strong quantitative and systems background
- Strong analytical thinking with problem solving approach and good ability to understand new data sources in short timeframe and embed them into standard analyses
- Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, Project plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
- Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g
- MS office, XML, Pinnacle 21)
- Expert in estimation and metrics; efficiently used metrics to bring change in process for better quality of delivery
- Management of one or more projects with a focus on delivery of the scope on time, within budget and with a high-quality outcome
- Worked on Platforms like Novartis data42, Nova Nordisk Clinical Data transformations, Merck Data Management Zero Gravity, DMW platforms
- Maintain modelling and naming standards, data harmonization, metadata management, and source-to-target data mapping documentation
- Engaged in data management and analytics projects, optimizing data flow (e.g., data capture, integration, validation)
- Have worked in data-related needs for various cross-R&D capabilities (e.g., data cleaning, master data management, data visualizations) and associated initiatives
- Design conceptual and logical data models and data dictionaries/ontologies to meet R&D business needs and functional requirements
- Planned for data validation process on physical data models
- Developed a proposal with the garage team to shorten the timeframes for the SDTM and ADaM standardization processes.
- Established comprehensive employee training programs to develop skills, improve productivity, and maintain compliance with industry regulations
Solution Implementation Lead
ClinAsia, A MAXISIT Group Company
Hyderabad
01.2016 - 02.2020
- Act as an SME, Respect departmental, corporate, and industry standards (e.g., NCI, CDISC) and procedures (GCDMP, ICH-GCP); evaluate and elucidate any further requirements at the project level
- Developed a strategy for automating ADaM and SDTM transformations using in house tools
- Program and plan the integration of databases from multiple studies or sources
- Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies
- Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications
- Coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc
- Validate and transform datasets as per client assignment specifications
- Validate tables, listings, and figures as per client assignment specifications
- Prepare SDTM and ADaM requirements in collaboration with biostatisticians
- Ensure quality assurance of all work product by team, adherence to delivery timelines and contractual SLAs
- Resolve critical support issues with a high degree of technical complexity
- Produced SDTM, ADaM datasets, and the TLF dashboards for customers such as Takeda, PMI, and Johnson & Johnson using in-house ETL tools and SAS, Tableau
- Lead RFP response actively in terms of solution architecture and design, effort estimations, risks and mitigation.
Solution Implementation Specialist
Solutions & Service, ClinAsia, A MAXISIT Group
Hyderabad
01.2012 - 01.2016
- Converting Client Raw Data to CDISC SDTM/ADaM data standards
- Validating the final output with open CDISC validator and subject level validation
- Applying Transpose, Append, Relationship, Data Filters and SAS Expressions after seeing Raw CDMS data to convert it to Standard CDISC Data
- Generation of SEQ, STDY, BLFL, MINDATE, MAXDATE
- Removing Duplicate records and Ignore records
- Generating Trial Design Dataset after reviewing the protocol, SV, SE and good exposure on Tumor domains
- Used needful Character, numeric and date functions
- Worked with different domains data like DM, AE, VS, IE, LB, CM, MH, SV, SE, EG, PE, QS and Trail Design
- Expert Knowledge in SDTM Devices IG
- Liaise with Data Management, Biostatistics, and Programming personnel
- Hands on experience on Operational Data mapping from different sources
- Monitoring project risks and scope creep to identify potential problems and proactively identifying solutions to address them in advance
- Manage and responsible for internal and external (ISO or Client) audit meetings
- Subject level validation with cardinality checks.
Delivery Engineer / ClinAsia
A MAXISIT Group
Hyderabad
08.2011 - 01.2012
- Gather requirements from clients for designing an in-house ETL, CRF, Protocol development solution with the appropriate feathers and features
- Define system design standards to standardize solutions, adhere to the architectural roadmap, and support their development, execution, and operations
- Accountable for the overall delivery of product/solution and related work
- Support definition, implementation and tracking of effectiveness of CDISC standard processes
- Review the logical and physical data model developed by Data modeler.
Education
Bachelor of Science - Computer Science Engineering
Nalla Malla Reddy Engineering College (Affiliated To JNTUH
Hyderabad 01.2004 - 05.2008
Skills
Project Management
undefinedTimeline
Asociate General Manager- Clinical Data Services
Clinical Data, Accenture Solutions Pvt Ltd
02.2020 - 08.2024
Solution Implementation Lead
ClinAsia, A MAXISIT Group Company
01.2016 - 02.2020
Solution Implementation Specialist
Solutions & Service, ClinAsia, A MAXISIT Group
01.2012 - 01.2016
Delivery Engineer / ClinAsia
A MAXISIT Group
08.2011 - 01.2012
Bachelor of Science - Computer Science Engineering
Nalla Malla Reddy Engineering College (Affiliated To JNTUH
01.2004 - 05.2008
Accomplishments
Automated source data to SDTM datasets, reducing mapping time from 3 months to 7 days then to 1 day per study.
· Worked with an EDC provider to create a Meta framework for source data collection by rebuilding the CRFs and maintaining a single database for all trials with no structural changes.
· Worked on the first part of automating SDTM to ADaM datasets using ETL tool.
· Worked on Phase-I, II and III studies of Oncology, Neurology, and Immunology therapeutic area.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
On-SiteRemoteHybridImportant To Me
Work-life balanceFlexible work hoursWork from home optionHealthcare benefitsTeam Building / Company RetreatsPersonal development programsQuote
Sell your cleverness and buy bewilderment.
Rumi
Software
Python
R
Oracle SQL
SQL Server
Microsoft Office
Power BI
Tableau
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
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