Associate Director, Statistical Programming

As the Associate Director of Statistical Programming at Orca Bio, your primary responsibilities include overseeing a team of statistical programmers to ensure high-quality programming support for clinical trials and regulatory submissions. You will be expected to manage programming oversight, ensuring that all statistical analysis datasets and reporting comply with industry standards and regulatory guidelines. Collaboration with cross-functional teams like biostatistics and clinical operations is crucial to align programming activities with study objectives. Plus, your role will involve driving process improvements, managing project timelines and budgets, and coordinating with vendors if needed.

To qualify for the Associate Director, Statistical Programming position at Orca Bio, you need at least a Master’s degree in Statistics, Computer Science, Life Sciences, or a related field, coupled with more than 10 years of statistical programming experience in the pharmaceutical or biotech industry. Additionally, having over 4 years in a leadership role is crucial, along with a proven track record in supporting clinical trials and regulatory submissions. Expertise in SAS programming and familiarity with CDISC standards are essential, while experience in oncology and cell therapy is preferred.

The Associate Director, Statistical Programming role at Orca Bio demands strong technical abilities, particularly in SAS programming (Base, Macro, SQL). Familiarity with other languages such as R or Python is a plus. You should possess an in-depth knowledge of CDISC standards like SDTM and ADaM, as well as regulatory requirements necessary for programming deliverables. Additionally, experience with clinical data management systems and data visualization tools will also be advantageous in this position.

At Orca Bio, professional growth is a priority, and as the Associate Director of Statistical Programming, you'll benefit from a culture that emphasizes mentorship and career development. You will be responsible for guiding your team, which includes providing performance management and training opportunities. The company encourages innovation and staying updated on industry trends, allowing you to grow your expertise and implement best practices that enhance your team's performance and the overall quality of work produced.

The anticipated annual salary range for the Associate Director, Statistical Programming role at Orca Bio is between $175,000 and $190,000. This range is influenced by various factors such as relevant experience, education, and local market conditions. Besides salary, this position also offers pre-IPO equity options and comprehensive benefits, including medical, dental, and vision coverage, flexible PTO, and additional perks like free lunches and snacks at on-site locations.

In responding to this question, be sure to highlight your specific experiences with different phases of clinical trials, emphasizing your programming skills and any tools you've used. Discuss how your role impacted the trial outcomes, particularly in ensuring data quality and regulatory compliance.

To answer this question effectively, choose a project that had multiple stakeholders or strict deadlines. Discuss the challenges faced, your approach to resolution, and the positive outcomes resulting from your management efforts, highlighting your leadership and problem-solving skills.

Explain your process for maintaining compliance with industry standards such as CDISC and regulatory guidelines. Include any experiences with audits, data verification processes, and collaboration with cross-functional teams that helped ensure the quality and compliance of your programming deliverables.

Here, it's important to reflect on your leadership style. Discuss strategies for motivating your team, such as setting clear goals, encouraging open communication, and providing professional development opportunities. Illustrating instances where your motivation tactics led to increased productivity can also be beneficial.

Detail the programming languages and tools you are most comfortable with, such as SAS, R, or Python, and explain the reasons for your preferences. Mention how these tools have enhanced your data analysis efficiency and the quality of your outputs in previous projects.

Share a specific scenario where you identified inefficiencies and took initiative to streamline processes. Discuss the steps you took, the outcomes of the adjustments, and how these changes benefited your team and the overall project.

Discuss the importance of communication and relationship-building with other departments. Share examples of successful collaborations that led to meaningful outcomes, emphasizing your interpersonal skills and ability to contribute positively to a team's dynamic.

Offer insights into the evolving nature of data management, regulatory changes, or the integration of new technologies. Position yourself as someone who stays updated on industry trends and how you foresee addressing these challenges in your role.

Acknowledge that errors can happen and emphasize the importance of immediate action. Discuss how you would identify the error, communicate with affected stakeholders, and implement corrective actions while ensuring that steps are taken to prevent future occurrences.

Convey your passion for improving patient outcomes and how Orca Bio’s mission aligns with your values. Discuss your excitement about leading a team within a company dedicated to innovative cell therapies, showcasing your desire to contribute to meaningful advancements in healthcare.