Ravikumar. katkam
xxxx.COM
+91 9xxxx
Professional Summary:
- Over 5+ years of experience in SAS programming with a strong emphasis on analysing Clinical Trial projects in the Pharmaceutical and Healthcare Industry.
- Proficient in SAS/Base, SAS/Macros, SAS ODS on Windows, and Unix environments (SAS versions 9.2, 9.3, and 9.4).
- Skilled in assisting group leaders with project management tasks, including scheduling project work, workload allocation, and timeline management.
- Experienced in attending project team meetings and providing technical advice on work plans.
- Expertise in generating SDTM, ADaM datasets, Tables, and Listings in compliance with FDA and other regulatory standards.
- Proficient in creating validation programs for analysis datasets and reports (TFLs).
- Adept at providing technical support for coding and debugging to other SAS programmers.
- Familiar with CDISC standards and clinical trial methodologies.
- Extensive experience in Phase I, II, III, and IV clinical trials across various therapeutic areas.
- Excellent analytical, presentation, communication, and problem-solving skills; able to work independently or in a team.
- Skilled in producing RTF and PDF formatted files using SAS ODS.
- Competent in UNIX environments, commands, and shell scripting.
Professional Skills:
SAS Skills: BASE-SAS, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ACCESS, SAS Enterprise Guide.
Programming Languages: SQL, SAS.
CDISC: SDTM, ADaM.
Education:
- Master of Pharmacy (First Class with Distinction) – Jawaharlal Nehru Technological University, 2014.
Professional Experience:
Senior Statistical Programmer
IQVIA (Home-based) – Dec 2014 to Present
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Recent Projects:
Project 1: A Randomized phase 3 study of MRTX949 versus Docetaxel in patients with previously treated Non-small cell lung cancer with KRAS G12C Mutation
- Therapeutic Area: Oncology.
- Role: Senior SAS Programmer.
Project 2: An Open-label Phase 1b Study of Active drug in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumours.
- Therapeutic Area: Oncology.
- Role: Senior SAS Programmer.
Project 3: Phase 1 Trial of Intralesional Immunotherapy with Active Drug Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma.
- Therapeutic Area: Oncology.
- Role: STAT-2 Programmer.
Project 4: A Phase-2 Open-label Multicentre Study of Single Agent Enzastaurin in Patients with Relapsed Cutaneous T-cell Lymphoma.
- Therapeutic Area: Oncology.
- Role: STAT-2 Programmer.
Project 5: Evaluating the Efficacy and Safety of Pembrolizumab Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial
- Therapeutic Area: Oncology.
- Role: STAT-2 Programmer.
Project 6: An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Solifenacin Succinate Tablets 10 mg with (Solifenacin Succinate) Tablets 10 mg in Healthy, Adult, Human Subjects Under Fasting Conditions.
- Therapeutic Area: Neurology.
- Role: Junior Programmer.
Responsibilities:
- Developing ADaM datasets as per specifications and reviewing them.
- Creating tables and listings in accordance with SAP and mock shells.
- Conducting project team meetings and providing technical advice on work plans.
- Documenting and tracking project-related progress.
- Assisting group leaders with project management tasks, including scheduling, workload allocation, and timeline management.
- Providing SAS programming expertise to produce ADS, Tables, and Listings from clinical trial data.
- Generating reports and listings using SAS/BASE, SAS/MACRO, SAS/SQL, and SAS/STAT.
- Updating ADaM specifications as per CDISC requirements and TLFs.
- Coordinating with the Data Management department on data issues and offline listings.