Ramakrishna Malneedi
Director / Group Lead - Statistical Programming, Gastrointestinal and Inflammation (GI2)Statistical and Quantitative Sciences (SQS)
- Role
- Director Group Lead - Statistical Programming, Gastrointestinal and Inflammation (Gi2) at Takeda
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Ramakrishna Malneedi
Over 25+ years of professional clinical research experience with 16+ years of rewarding programming leadership career in global clinical (people/project/portfolio) management, worked in the increasing roles of responsibilities from a Manager through Director of Clinical/Statistical Programming on multiple portfolios/assets for Pharmaceutical, Biotech and CRO companies executing director-level accountability and responsibilities in terms of driving the strategy, hiring, building and leading highly productive programming teams in the size of 50+ team members, promoting departmental initiatives development, serving as Programming representative on SOP/Process improvements, facilitating cross-functional collaboration within Biometrics and professional development of team members and also effectively liaising with cross-functional areas like Data Management/Operations, Bio-statistics, QA, Medical Writing, Regulatory Affairs, Medical, Clinical & Drug Safety etc. coupled with many years of prior hands-on experience as a Senior /Lead Statistical Programmer using SAS. Gained dependable working knowledge and understanding of GCP, Code of Federal Regulations (21 CFR Part 11), ICH, FDA and various industry standards like CDISC, SDTM, ADaM and CDASH etc. and PMBOK project management standards.
Experience
Director Group Lead - Statistical Programming, Gastrointestinal and Inflammation (Gi2)
May 2023 — Present · Philadelphia, PA, US
Education
Maharastra, India
Bachelor's degree (B.S) in Computer Science and Engineering
Skills
- Pharmacovigilance
- Clinical Trials
- Trial Management
- IT Management
- Gcp
- Regulatory Affairs
- Edc
- Ctms
- Bio-Statistics
- Clinical Data Management
- Sas Programming
- Clinical Project Management
- CRO
- Cdisc
- Medical Writing
- Biostatistics
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