Dr. Sigrid Balser

Defining and negotiating efficient development programs for biosimilar products in alignment with Health Authorities. Vendor oversight for all biostatistics, data management, statistical programming, and medical writing activities. Ensure high quality scientific contributions to the design, conduct, and analysis of clinical trials. Vendor oversight for all biostatistics, data management, statistical programming, and medical writing activities

Defining the strategic statistical direction of all Sandoz Biopharmaceuticals development programs. Leading a team that provides biostatistics contributions to all programs as well as planning and coordination of regulatory submissions. Influencing the environment by attending Health Authority meetings and workshops to identify opportunities to foster and drive the full integration of modern aspects of drug development including model-based approaches and innovative statistical methodologies.

Leading a team of (pre)clinical operations and biostatistics specialists who drive the design, conduct, and analysis of all pre-clinical, clinical, and medical affairs studies.

Supervision of all data management, statistics, and medical writing activities with the Biopharmaceutical Clinical Development Department, covering all aspects from pre-clinical studies to late phase programs Project statistician for key programs Strategic input into development plans, Health Authority interactions, and development of biosimilar guidelines

Statistical management of all pre-clinical and clinical trials for the development of biosimilars, including design, sample size calculation, data cleaning process, analysis and reporting Support of analytical lab for assay validation and review of lab results Coordination of Modeling & Simulation activities in collaboration with Novartis, Basel Participation in Scientific Advice meetings with EMA and FDA as well as interactions with the WHO for the development of biosimilar guidelines

Complete project management of two Phase III trials for approval of a biosimilar epoetin as well as of various bioequivalence trials with a large variety of complex and small molecule generics Statistical management of all clinical trials, including design, sample size calculation, data cleaning, analysis and reporting Writing the statistical parts of the study protocol and the statistical analysis plan Coordination und surveillance of the data management and statistics activities conducted by CROs

(Statistical) Design and planning of clinical trials (Phase I – III) Writing or review of the statistical part of the study protocol as well as of the statistical analysis plan and the integrated study report Organization and review of data management activities and statistical analyses and reports provided by the CROs Additional exploratory analyses and compilation of the data and of the results for international authorities Writing publications for journals and conferences

Project manager for various clinical trials and post-marketing surveillance studies Supervision of data entry, data management, and statistics Statistical Analysis of phase III/IV clinical trials and post-marketing surveillance studies including statistical input to the study design, sample size calculations, CRF design, and the statistical analysis plan Presentation of the results at the sponsor’s site Budgeting and preparation of offers to sponsors

Statistical analysis of international Phase I – IV studies and of post-marketing surveillance studies Design and writing of statistical analysis plans, of statistical reports, and of the statistical section of the integrated clinical report Development of SAS macros and maintenance of the SAS macro library Validation of SAS programs and data plausibility checks

Statistics / statistical process control

Statistik