Ramalinga Reddy

Statistical Programmer with professional work experience of 7.8 years. Adept at making critical decisions, managing deadlines and conducting team reviews. Working exclusively under Programming activities domain across phases of clinical trial. With expertise in CDISC standard, analysis and quantitative problem-solving skills, dedicated to company growth and improvements.

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.

B. Tech - Jawaharlal Nehru Technological University, Anantapur Andhra Pradesh, India