Senior Director of Biostatistics

The Senior Director of Biostatistics at Formation Bio will lead all statistical activities related to clinical trials, including study design, data interpretation, and regulatory submissions. This role requires overseeing the development of statistical strategies for important programs, collaborating on regulatory documents, and ensuring compliance with data submission guidelines.

To qualify for the Senior Director of Biostatistics position at Formation Bio, candidates should possess an M.S. or Ph.D. in Statistics or Biostatistics. Additionally, candidates must have at least 8 years of relevant experience in the pharmaceutical or biotechnology industry, a strong understanding of ICH guidelines, and proven statistical execution experience in clinical trials.

The Senior Director of Biostatistics contributes to drug development at Formation Bio by leading the statistical strategy for clinical programs, designing studies that influence clinical development plans, and performing simulations to evaluate study design options. This strategic input is vital for guiding clinical trials towards regulatory approval and ultimately enhancing patient access to new medicines.

Yes, prior regulatory experience is essential for the Senior Director of Biostatistics role at Formation Bio. Candidates must have a deep understanding of biostatistics regulatory requirements and guidelines, along with significant experience in interactions with health authority agencies such as the FDA and EMA, especially in relation to NDA/BLA submissions.

Candidates applying for the Senior Director of Biostatistics role at Formation Bio should be proficient in statistical software used for clinical trial design and analysis, such as SAS, R, EAST, and FACTS. Advanced R programming skills are preferred to successfully drive various quantitative analyses and support innovative study designs.

When answering this question, outline specific statistical methodologies you’ve applied in past clinical trials. Discuss any innovative approaches you've used, as well as how these methodologies influenced study outcomes and regulatory approvals.

Explain your process for trial design, including any frameworks or software tools you rely on. Highlight how your designs have contributed to successful regulatory submissions or positive patient outcomes.

Demonstrate your understanding of ICH guidelines by summarizing key aspects that impact study design and data analysis. Discuss how you have applied these guidelines in your previous roles to ensure compliance.

Describe a specific statistical challenge you faced, how you tackled it, and the outcome. This showcases your problem-solving skills and ability to turn data issues into actionable solutions.

Discuss your strategies for translating complex statistical analyses into understandable insights for non-experts. Emphasize the importance of collaboration and clear communication in your role.

If you have worked with Bayesian methods, describe your experience and how these techniques influenced decisions in clinical trials. If not, discuss your familiarity and any intention to learn about them further.

Explain your approach to ensuring GCP compliance, including any processes or checks you implement during clinical study execution. Highlight past experiences of maintaining high standards in study conduct.

Discuss how you utilize simulation studies to evaluate clinical trial design options and help determine go/no-go decisions. Providing specific examples can help illustrate your approach.

Share relevant experiences and skills that make you a strong candidate for this role. Focus on your passion for drug development and innovative thinking in biostatistics, aligning your values with Formation Bio’s mission.

Describe your experience managing CRO/vendor relationships, detailing your strategies for ensuring they align with project goals and maintain data integrity. Discuss how you track performance and address any issues that arise.