Senior Statistical Programmer - Vertexone Process Solutions - Bengaluru
(2024-07 - 2025-01)
- Lead studies by providing technical and project leadership, ensuring the delivery of high-quality outputs through adherence to standards, regulatory guidelines, and internal SOPs and work practices.
- Review key documents such as the Statistical Analysis Plan (SAP), Data Review Plan and annotated CRF (aCRF) to ensure consistency with team objectives and clear programming requirements.
- Evaluate the impact on timelines based on scope of statistical programming.
- Proactively taken the responsibility of package lead for ADaM and TLF's.
- Provided ad-hoc support for TFL deliverables to multiple stake holders.
- Involved in preparation of EMA listings and datasets for regulatory submission.
- Performing troubleshoot and resolve programming issues independently and also support study team for the same.
- Monitoring vendor team to ensure error free and quality deliverables of outputs and SDTM/ADaM datasets.
- Closely collaborated with the study and compound statisticians, medical writing team for the required delivery.
- Closely collaborated with data management team to ensure data quality maintained for each deliverable.
- knowledge in creating tables and listings programming for ISS Integrated Summary of Safety and ISE Integrated Summary of Efficacy to the FDA.
Sr Developer - Relanto Global Private Limited - Bengaluru
(2023-09 - 2024-06)
- Provided leadership for leading the studies and ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements.
- Performed creation and validation of ADaM datasets (Safety and Efficacy) along with specification creation with TLF's mock shell review.
- Created Required TLF's (Safety and Efficacy) based on mock shell and Statistical team input.
- Provided programming support for project teams including development of programming strategies, standards, specifications and programmed analysis.
- Provided Support for the electronic submission package.
- Reviewed key planning documents (e.g., statistical analysis plan, List of analysis, data review plan, aCRF) to ensure alignment with study objectives and organizational standard.
- Monitoring and mentoring study team by providing knowledge sharing session and ensuring quality outputs should delivered for every milestone.
Sr Software Engineer - Globallogic - Hyderabad
(2022-12 - 2023-06)
- Performed various ADaM datasets like ADSL ADAE, ADMH, ADCM, ADLB, ADVS etc. with minimal to no findings for Sponsor.
- Perform the necessary updates as per Pinnacle 21 (Enterprise version) report and provide comments as per study requirement.
- Modification of standard macro and creation of new macros as per study requirements.
- Individual handing initial project, Post Production changes as per protocol amendments and SAP.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work.
Consultant-I - Exl Services - Bengaluru
(2020-12 - 2022-12)
- Independently leads and performs programming assignments.
- Develop custom coding reports for data review as per medical data review requirement.
- Support improvement initiatives for the study support forstat programming.
- Involvement in preparing of training plans for new team members and used to provide training.
- Worked on the Define package and adrg document.
- Excellent organizational and communication skills with high self-motivation, team leadership experience.
- Individually capable of developing new SAS Programs and/or enhancing existing SAS programs.
- Experience in debugging and testing SAS programs to check and process data, generate tables and listings in analysis system.
Programmer Analyst - Dr Reddys - Bengaluru
(2016-06 - 2020-03)
- Broad Knowledge of Life Sciences and drug development process from protocol through FDA submissions in the clinical trial process Phase I-IV.
- Trained on acrf document.
- Worked on the listings.
- Working experience in Data cleaning and edit checks.
- Performs clinical data review for data issues, Interact with Clinical Data Management team and escalates any issues.
- Possess a strong ability to adapt and learn new technologies and new business lines rapidly.
