United States onlyPosition 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.
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.
