Endri Elnadav

Identify necessary improvements to common processes for data management and statistical programming Create a way for drastically accelerating the programming processes for streamlining the drug development process

- On Behalf of DataFocus, working as Statistical Programmer at Bayer Healthcare, Berlin - Responsible for study analysis of phase I-IV and programming of urgent requests from authorities (EMEA, FDA, HEOR, etc.) and for other submissions / litigation purpose - Develop and validate SAS programs of derived datasets and creation of Table / Figure / Listing using CDISC/SDTM datasets

CDISC Mapping ADaM Mapping Creation of TFL Data Analysis SAS (Base, Stat, Graph, Macros, SQL)

- Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents with SAS 9.1.3. - Use efficient programming techniques to produce and/or QC low-medium complexity derived DTFLs.. - Ensure quality control (QC) on all process and technical activities related to derived DTFL programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.

- Responsibilities included the development of ICH-GCP compliant SAS-programs (Statistical Analysis System) for Databases Setup, Database Quality Checks and Listings. - Creating clinical datasets in CDISC SDTM or client specific format from various data source - Reporting Query Management - Validation and Review of Mapping scripts, Reporting Database / Listing - Development, Validation & Review of (standard) Macros for SDTM Datasets