Data Manager & Statistical Programmer

20 years of extensive expertise in clinical research and CDISC standards ensures high-quality, compliant data analysis across all phases of clinical trials

Advanced SAS programming skills, including macro development and automation, enable efficient implementation of complex statistical methods

Strong cross-functional collaboration experience supports seamless coordination between Data Management, Statistical Programming, and other departments

Proven regulatory submission and compliance know-how, including define.xml, SDTM/ADaM datasets, and ISS/ISE preparation, ensures readiness for audits and approvals

Clinical research in accordance with ICH-GCP guidelines

Drug approval submissions

All clinical trial phases: planning, data collection, data processing, and statistical analysis

Implementation of CDISC standards (SDTM, AdaM, define.xml)

SAS programming, including development of macros for process automation

Application of both standard and advanced statistical methods

Collaboration with interdisciplinary teams and coordination of cross-functional requirements

Consulting on process optimization and contribution to the development of SOPs

Regulatory compliance and high-quality standards through a risk-based approach

Continuous professional development to stay current with industry-specific methodologies and technologies

Creation of re-usable macros, programs for creation of standard tables and figures. Implementation and automating of non-standard sophisticated statistical methods (SAS/PROC IML)

Consulting for Process setup and SOP development in the area of programming; SAP review; SDTM mapping; Creation of QC Plan for programming activities

Creation of ISS analysis and periodic drug safety reports

Creation of listings for internal medical review; Biomarker analyses

Coordination of collaboration with CRO; Review CSR; Creation of ADaM datasets; Creation of SDTM/ADaM- define.xml for several studies and support in submission activities

Statistical consulting and analysis of epidemiological data; Support in the statistical part of publications

Continuous collaboration at various oncology studies. Review and programming of analysis datasets, tables, listings and Figures

Processing of RECIST data; Explorative analysis; Review/Creation of ISS; Preparation and participation at DMCs; SAP and programming specification review; Submission Support; Generation of patient profiles; Interaction with other functions such as medical development and data management

Development, testing and improvement of processes for implementation of CDISC standards (SDTM, ADaM and define): design of related standard templates, SAS programs and macros, SOPs and WIs, trainings on implemented processes

Lead Programmer for a legacy SDTM mapping of an observational safety follow-up study including AP domains

Creation of SDTM-annotated CRF, SDTM datasets and ADaM/SDTM-define.xml; Support and consultancy with data cleaning activities; Write SAP; Creation of quarterly reports

Creation of tables, listings and ADaM datasets for dermatology studies. SAP review; General consultancy concerning the organisation of programming

General consultancy concerning SDTM and define.xml; Review of annotated CRFs; Programming of SDTM datasets

Creation of analysis datasets, tables and figures for a bioequivalence study

Double programming of ADaM-datasets; review of SAP and statistical output

Specification and programming of SDTM and ADaM datasets for a bioequivalence study

Efficacy and safety analysis for oncology NIS