Principal/Senior Therapeutic Methodology Statistician

Summary

Join our client as a TAM Statistician and collaborate with other statisticians, providing statistical-methodological expertise in areas such as integrating external data into clinical development reports, patient-focused drug development, and clinical trial design. You will evaluate advanced statistical methods, develop tool kits, and implement them on a large scale. Provide pragmatic solutions to clinical development teams, present complex statistical concepts to stakeholders, and deliver statistical-methodological training. Mentor colleagues, supervise interns and students, and contribute to their professional development. This is a fully remote opportunity.

Requirements

• Master of Science (MSc) or Doctoral Degree (PhD) from an accredited institution, in Statistics or Mathematics or related field (Psychology, Data Science, Finance, etc.)
• At least five (5) years of experience as a statistician or data scientist in an area relevant for the specific role

Responsibilities

• Closely collaborate with other statisticians and provide statistical-methodological expertise on multiple of the following topics including: Integration of external data into clinical development and HTA reports, e.g. via usage of Bayesian borrowing and external control complex evidence synthesis including Bayesian network meta-analysis patient-focused drug development including clinical endpoint development and psychometric validation of instruments clinical trial design that enables RCT to real world populations and settings, for example, pragmatic trial and flexible augmented clinical trial for improved evidence generation (FACTIVE) target trial emulation, causal inference and real world evidence methodology
• Evaluate advanced statistical methods to foster holistic evidence generation by prototyping and developing ready-to-use tool kits
• Drive the implementation of ready-to-use tool kits
• Contribute to the large-scale implementation for such innovation tool kits
• Provide pragmatic solutions to our clinical development teams to foster holistic evidence generation that accompanies needs for different stakeholders including internal decision making, regulatory, market access and medical affairs
• Present and illustrate the application of complex statistical concepts to stakeholders like management, external partners, and/or regulatory agencies
• Provide statistical-methodological trainings to statisticians and non-statisticians
• Mentor and guide other colleagues
• Define and supervise the technical and scientific work of interns and students and contribute to their professional journey

Preferred Qualifications

• Master of Science (MSc) or Doctoral Degree (PhD) from an accredited institution, in Statistics or Mathematics or related field (Psychology, Data Science, Finance, etc.)
• At least seven (7) years of experience as a statistician or data scientist in an area relevant for the specific role
• Working experience might be partially compensated by broad and deep topic-specific knowledge, e.g. with respect to statistical methodology
• Statistical experience gained in an international context and ideally in different companies/ academic institutions
• Ideally, additional qualification and experience in a leadership role
• In-depth knowledge of competitor and agency strategies and/or in-depth knowledge regarding statistical approaches developed and implemented by other companies or academia in a global context
• In-depth knowledge of parts of BDS and related parts of other organizations at BI regarding their contribution to BIs strategy
• In-depth knowledge of statistical methodology and clinical development
• In-depth understanding of statistical concepts related to clinical development
• Ability to supervise scientific/technical work
• Proficient in the use of software languages to implement statistical concepts
• Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively
• Ability to lead and facilitate meetings required
• Evidence of strong teamwork, ideally also in global and remote context
• Very good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., CROs, experts, management)
• Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on statistical topics
• Language skills: English: fluent (Read/Write/Speak)
• Know, understand, and implement: International regulations and guidelines for good clinical and statistical practice from all ICH regions The various international guidelines on clinical development, data standardization, and BI processes and SOPs that govern clinical development in particular with respect to strategic areas e.g. Clinical Development Plan)

Benefits

FULLY REMOTE OPPORTUNITY