Associate Director, Biostatistics

Associate Director, Biostatistics

BeiGene

Remote, Switzerland

General Description:

We are looking for a highly motivated, proactive, and strategic statistician with strong expertise in EU HTA methodologies to join the SGPAR team and provide statistical solutions to meet EU HTA requirements, including requirements for the EU Joint Clinical Assessment (JCA) and help shape new ways of working and organizational readiness. This role requires close collaboration with multiple functions, including HEOR, Market Access, Clinical Development, Regulatory, Medical Affairs.

Essential Functions of the job:

• 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.

Responsibilities:

• 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.

Qualifications:

• 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.

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