SAS Programmer

Nearly 30 years of experience as Statistical Programmer with focus on SAS Programming

Extended knowledge with Clinical Data Standards

Successfully placed as SAS Programmer via K-Recruiting

Has strong experience in stakeholder management

Health economics projects primarily to support dossiers for the German authorities

Involved in every aspect of programming – update of existing general macros, creation of TFLs, and sometimes creation of specifications for analysis datasets

Working with MMRM and return rates and TTE (with Kaplan Meier plots), and quality of life, mapping changes from baseline

Programming SDTM, ADaM & TFLs for a Covid-19 study

Working on both Phase II and Phase III parts of the Study, creating SDTM and ADaM specs and carrying out validation of the datasets included

Working on ADaM datasets for an ISS combining 12 studies, and solving arising issues

Using Pinnacle21 as part of the checks

Validation of SDTM, ADaM and TFLs for small CRO on a project on intravenous anesthesia for elective surgery

Using double programming and Pinnacle21 Enterprise for checking the integrity & conformance of the datasets to CDISC standards in preparation for submission

Mentoring junior programmers

Providing SAS programming support for data management teams in non-interventional studies (NIS) and working to CDISC standards

Developed the metadata for each study, and liaised with the end-client to achieve approval

Working with the approved metadata and both WHODICT and MedDRA

Developed programs for each SDTM domain in line with

SDTM v1.2 and either SDTMIG 3.2 or 3.3, depending on the study; the output was validated with Pinnacle21

Automated data checks for data managers by writing programs, standardizing input and output Excel sheets using PROC SQL and VBA

Structured input and output streamlined data checks in SAS, saving time, effort, and costs

Providing programming support on various Real World Evidence (RWE) studies

Working with CDISC ADaMIG v1.2 and more

Co-responsible for creating ADaM specs and coding

Advised statisticians on programming requirements and output validation for ADaMs and TFLs

Providing programming support on diverse studies, mainly Real World Evidence (RWE)

Collaborated with clinical, data management, and statisticians to ensure quality deliverables

Review of dataset specifications, development and validation of analysis datasets and TFLs

Key role in pooling safety data for several studies, recreating ADaM datasets and producing TFLs

Validation of other outputs and developing ADRG