Associate Director, Statistical Programming

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary:

The Associate Director of Statistical Programming will work independently and may lead a team of statistical programmers to deliver high-quality statistical programming support for clinical trials and regulatory submissions in the pharmaceutical industry. This role involves strategic oversight, technical expertise, and collaboration with cross-functional teams to ensure programming deliverables meet timelines, quality standards, and regulatory requirements.

Essential Duties & Key Responsibilities:

• Leadership & Management: Oversee a team of statistical programmers, providing mentorship, performance management, and career development. Allocate resources effectively to meet project demands.
• Programming Oversight: Ensure development, validation, and maintenance of statistical analysis datasets, tables, listings, and figures (TLFs) per study protocols and statistical analysis plans.
• Regulatory Compliance: Guarantee programming deliverables comply with industry standards (e.g., CDISC, SDTM, ADaM) and regulatory guidelines (FDA, EMA, etc.).
• Cross-Functional Collaboration: Partner with biostatistics, data management, clinical operations, and regulatory affairs teams to align programming activities with study objectives.
• Process Improvement: Drive the development and implementation of programming standards, templates, and automation tools to enhance efficiency and quality.
• Project Management: Manage timelines, budgets, and deliverables for multiple projects, ensuring milestones are met within scope.
• Vendor Oversight: Coordinate with external vendors or contract research organizations (CROs) as needed to ensure consistency and quality of outsourced programming work.
• Innovation: Stay updated on industry trends, emerging technologies, and best practices to integrate innovative solutions into programming workflows.

Minimum Experience & Education:

• Minimum Experience & Education:
• Master’s degree or above in Statistics, Computer Science, Life Sciences, or a related field.
• 10+ years of statistical programming experience in the pharmaceutical or biotech industry.
• 4+ years in a leadership or supervisory role.
• Proven track record in supporting clinical trials (Phase I-IV) and regulatory submissions.
• Preferred: Experience with oncology, cell therapy, and/or complex therapeutic areas.
• Technical Skills:
• Expertise in SAS programming (Base, Macro, SQL); familiarity with R or Python is a plus.
• In-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements.
• Experience with data visualization tools and clinical data management systems.
• Soft Skills:
• Strong leadership and team-building capabilities.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Problem-solving mindset with attention to detail and accuracy.

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.