Associate Director, Biostatistics

BeOne Medicines I GmbH; Schweiz; Vor Ort; CHF 164.000 - 205.000; Vollzeit

Zusammenfassung

BeOne Medicines I GmbH is seeking an experienced statistician to support EU HTA submissions, including the EU Joint Clinical Assessment (JCA). You will collaborate with HEOR, Market Access, Regulatory, and other functions to develop robust statistical analyses and models for European submissions.

The role requires PhD or equivalent in Statistics/Biostatistics (or Master with extensive HTA experience), strong SAS/R skills, and fluency in English.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

HTA methodology

EU JCA

English communication

Cross-functional collaboration

Statistical programming

Ausbildung

PhD in Statistics/Biostatistics

Master's degree with 7+ years

Tools

SAS

R

Jobbeschreibung

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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.

Travel

Yes, depends on needs.

Salary Range Switzerland: 164,100.00 CHF - 205,100.00 CHF

Salary Range UK: 77,400.00 GBP - 96,700.00 GBP

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.