Franklin Moses
Manager Statistical Programming at SENSAN BIOSCIENCES - Driving Data Insights & Innovation in Biostatistics | End to End Clinical Statistical Programmer | ICH GCP Certified Clinical Trial Professional
- Role
- Manager Statistical Programming at SENSAN BIOSCIENCES
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Franklin Moses
Over 15+ years varied experience in Life science domain as Subject Matter Expert, Team Lead - Regulatory Associate in Regulatory operations, Clinical SAS Programmer for Developing Agency specific SDTM, ADaM, Datasets, TLF, DefineXML packaging, ISS/ISE, BIMO, RMP and PK/PD NONMEM Clinical Data Analysis.Core competency in pharmaceutical regulatory compliance, requirement elicitation, UAT, business analysis, technology services, Product testing, team management.Special Clinical SAS Domain Skills: Base SAS programming, CRF Annotations, Define XML Creations, CRT Preparations, SDTM & ADAM Standardization, TLF Programming and PK/PD NONMEM Data analysis. Regulatory Domain Specialties: US-FDA, Health Canada submissions procedures - ANDA, DMF, NDA. European (EMEA) submissions procedures- eCTD/NeeS - CP, DCP, MRP, NP.AFME & EME regions and LATAM region Publishing.Publishing Applications (eCTD/SPL/NeeS): PharmaReady,eCTDXpress,ISI Publisher,ISI toolbox, Liquent-Insight publisher and eTMF.
Experience
Manager Statistical Programming
Apr 2025 — Present
Education
Anna University
Bachelor of Engineering (B.E.), Electronics and communication
2007
SA Polytechic
Diploma, Electronic and communication
2004
RMHSS
HSLC, Computer Science
2002
Skills
- 21 Cfr Part 11
- Sas Programming
- Isi Toolbox
- Eu-Publishing
- Life Sciences
- Pharmaceutics
- Pharmacovigilance
- Nees
- Latam Submissions
- Clinical Trials
- Validation
- Documentum
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Submissions
- Regulatory Requirements
- Sdtm
- Publishing
- Ectd
- Spl
- Regulatory Affairs
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