Vice President Biostatistics

The Vice President of Biostatistics at Acadia Pharmaceuticals oversees a range of advanced biometrical and statistical activities aimed at analyzing and interpreting statistical data. This role includes managing SAS programming workflows, leading a dedicated team, developing clinical study plans, and directing the statistical analysis of clinical trials data. Collaboration with clinical leads to create effective clinical development plans is crucial, as well as ensuring compliance with industry standards and regulations.

Candidates for the Vice President of Biostatistics role at Acadia Pharmaceuticals should hold an advanced degree (MD, PharmD, or PhD) in Biostatistics or a related field. A minimum of 10 years of leadership experience in the biopharmaceutical industry, focusing on clinical research and biostatistics, is essential. The role requires deep knowledge of statistical processes and SAS programming, along with strong strategic thinking and leadership skills.

The Vice President of Biostatistics plays a critical role in representing Acadia Pharmaceuticals during regulatory interactions. This individual is responsible for overseeing the design and quality assurance of biostatistical components for clinical submissions, thereby ensuring that the analyses presented meet regulatory standards. Their expertise influences the direction of discussions with regulatory bodies, shaping the future of our clinical trials and drug development strategies.

The Vice President of Biostatistics position at Acadia Pharmaceuticals combines an engaging and collaborative work environment with the flexibility of hybrid work arrangements. Employees will regularly engage with cross-functional teams, both in-person at the Princeton headquarters and remotely. The role demands effective communication and project management skills to navigate a dynamic environment where priorities can shift.

Compliance is of utmost importance in the Vice President of Biostatistics role at Acadia Pharmaceuticals. This position requires a thorough understanding of Good Clinical Practices (GCP), International Conference on Harmonisation (ICH) guidelines, and 21 CFR part 11 regulations. The VP ensures that all statistical analyses and technological infrastructures comply with these regulations, thereby safeguarding the integrity and quality of data in clinical trials.

When asked about your leadership style, focus on your collaborative approach and your ability to inspire your team towards shared goals. Highlight your experience managing cross-functional teams, encouraging open communication, and developing team members' skills. Providing specific examples of successful projects where your leadership was instrumental can be very effective.

Discuss your methodology for prioritizing projects based on their clinical impact, deadlines, and resource availability. You might mention using project management tools, regular team check-ins, and adaptive planning techniques that allow you to be flexible as priorities shift. Illustrate your answer with an example where your prioritization skills resulted in successful project outcomes.

When answering this question, emphasize your experience with regulatory compliance, quality control processes, and the importance of good clinical practices. Talk about the checks and balances you implement within your teams, such as regular audits, training on data management protocols, and how you foster a culture of accountability and attention to detail.

You can address this by discussing the importance of clear communication and setting realistic timelines. Explain how you keep stakeholders informed through regular updates and meetings, and how you actively seek to understand their concerns and adjust strategies accordingly. It's effective to include a specific instance where you effectively managed stakeholder expectations under challenging circumstances.

Choose a significant project that showcases your statistical acumen and leadership. Describe the complexity of the analysis, the methodologies employed, and how you navigated any difficulties encountered. Be sure to highlight the implications of your findings and how they benefited the clinical program or organization.

Share your insights on current trends in biostatistics, such as machine learning integration or advances in statistical methodologies for clinical trials. Discuss how these advancements can improve efficiencies or enhance data analysis. Showing enthusiasm for ongoing developments will demonstrate that you are a forward-thinking candidate.

Talk about your systematic approach to compliance, which could include ongoing education for your team, regular audits of your processes, and engagement with regulatory bodies. Highlight your commitment to maintaining high standards and how this is ingrained in your departmental culture. Providing specific examples would strengthen your response.

Discuss your strategies for fostering diversity in recruitment, mentorship, and team development. Emphasize the importance of varied perspectives in scientific research and how you create an inclusive environment where all team members feel valued and encouraged to contribute. Share any success stories related to diversity initiatives in your past roles.

Identify key performance indicators relevant to biostatistics, such as data accuracy, time to analysis completion, and adherence to regulatory timelines. Detail how you monitor these metrics throughout the trial phases, making adjustments based on the data you gather to ensure optimal performance and outcomes.

Explain your approach by emphasizing transparent communication with key stakeholders and a commitment to thorough analysis before reaching conclusions. Discuss the importance of conducting exploratory analyses to understand the results fully and how you would collaborate with your team to come up with an action plan based on findings.