Associate Director, Biostatistics

Darum lohnt es sich

Responsibilities • Close collaboration with cross-functional teams to support the quantitative needs for HTA submissions in Europe • Provide strategic statistical input into evidence generation activities and analyses required for the EU JCA • Provide quantitative support for local HTA adaptations • Influence and shape new ways of working to ensure organizational readiness to successfully meet the needs of the EU JCA • Serve as a subject matter expert in relevant EU cross‑functional teams • Collaborate with HEOR and external vendors to build models in support of EU submissions with a focus on HTA/JCA analysis. • Attend advisory board meetings and internal strategic meetings and provide statistical analysis input. • Work with the statistical programming staff to ensure that all programs meet internal and external analysis requirements. • Contribute significantly in providing key and innovative ways to data analyses, including the interpretation of results and the presentation to leadership of findings. • Keep up to date with respect to statistical methodology in HTA and use efficient or innovative approaches in economic modeling, indirect comparisons, and observational studies. • Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of studies, and be able to propose and implement solutions. • Serve as the statistical subject matter expert in cross‑functional teams. • Contribute to creation/maintenance of, and provide training on, statistical topics and departmental SOPs, work instructions, etc. • Provide quantitative support to address the needs for local adaptations and adhoc HTA requests. • Ensure consistency and adherence to standards across compounds and/or therapeutic areas. • Review vendor‑supplied data and analysis as needed.

Requirements • PhD or equivalent degree in Statistics/Biostatistics or related discipline with a minimum of 5 years relevant work experience, or a Master’s degree with a minimum of 7 years relevant work experience. • Significant experience in HTA in Europe and other major markets. • Solid knowledge of statistical analysis methodologies and experimental design. • Proficient in statistical and data processing software such as SAS and R. • Good presentation, oral and written communication skills in English. • Ability to learn, be proactive, motivated, and consistently focus on details and execution. • Strong interest in statistical research activities and application of novel methods to clinical trial development. • Ability to work in a team environment with multiple cross‑functional team members. • Knowledge of clinical trial design concepts; in-depth knowledge of all phases of the drug development process. • Demonstrated skills in the planning, analysis and reporting of clinical trials.