The Director/Senior Director, Biostatistical Programming will provide strategic and operational leadership for statistical programming across clinical development programs. This individual will serve as the senior-most programming leader within Biometrics, reporting directly to the Head of Biometrics, and will oversee a high-performing team of approximately 12 15 statistical programmers supporting multiple studies and regulatory submissions.
The successful candidate will drive programming standards, processes, innovation, and execution excellence across all phases of development while partnering closely with Biostatistics, Data Management, Clinical Development, Regulatory, and external vendors. This role requires a strong leader with deep technical expertise, global regulatory submission experience, and the ability to build scalable programming capabilities in a fast-paced biotechnology environment.
- Lead, mentor, and develop a team of approximately 12 15 statistical programmers, including managers, senior programmers, and contractors.
- Serve as the functional head of Statistical Programming and primary programming representative within Biometrics leadership.
- Provide strategic oversight for programming activities supporting clinical trials, integrated analyses, regulatory submissions, publications, and health authority interactions.
- Establish and maintain programming standards, SOPs, processes, and best practices aligned with industry and regulatory expectations.
- Ensure high-quality and timely delivery of SDTM, ADaM, TLFs, datasets, and submission packages across development programs.
- Drive consistency and efficiency through automation, innovation, and implementation of modern programming technologies and workflows.
- Collaborate closely with Biostatistics leadership on study design, analysis planning, resource forecasting, and submission strategy.
- Oversee CRO and vendor programming activities, including governance, quality oversight, timelines, and deliverables.
- Provide strategic input into regulatory submissions, inspections, and responses to health authority questions.
- Partner cross-functionally with Clinical Development, Data Management, Medical Writing, Regulatory Affairs, and Clinical Operations to ensure alignment across programs.
- Build and maintain a scalable organizational structure to support portfolio growth and evolving business needs.
- Contribute to departmental strategy, budget planning, hiring, and long-term capability development.
- Foster a culture of quality, accountability, collaboration, and continuous improvement.
- Advanced degree in Statistics, Biostatistics, Computer Science, Mathematics, or related scientific discipline preferred.
- 12+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry, including leadership experience.
- Prior experience leading global programming teams and managing direct reports.
- Extensive hands-on expertise with SAS and CDISC standards (SDTM, ADaM).
- Strong knowledge of regulatory requirements and submission standards for FDA, EMA, and other global health authorities.
- Proven experience supporting NDA/BLA/MAA submissions and regulatory inspections.
- Demonstrated ability to lead programming strategy across multiple concurrent clinical development programs.
- Strong project management, communication, and stakeholder management skills.
- Experience working in a fast-paced, matrixed, and highly collaborative environment.
- Knowledge of R, automation platforms, or modern data science/programming approaches is a plus.
- Strategic and enterprise-minded leadership approach
- Strong people development and coaching capabilities
- Ability to influence across functions and organizational levels
- Operational excellence with attention to quality and execution
- Collaborative, solution-oriented mindset
- Ability to balance strategic thinking with hands-on leadership
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
