Senior Director, Statistical Programming

Position Overview

The Senior Director of Statistical Programming provides leadership and oversight across clinical programs within Statistical Programming function.  This position will require managing programming resources, assisting in development of Programming infrastructure and process, providing technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements. This role requires high-level oversight of CRO partners, technology innovation, and cross-functional leadership.

Responsibilities

• Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and values.
• Provide management and oversight of statistical programming resources including FTEs, contractors and CROs involved in early-stage and late-stage studies.
• Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables. Provide hands-on programming, if required, of critical ADAMs and TLFs.
• Demonstrate strong technical expertise to promote best practices related programming environments, technology and programming skillsets
• Develop and ensure conformation to Programming SOPs and Work Practice guidelines
• Maintain strategy for capability and skill development to meet current and future requirements.
• Maintain an environment to foster creativity and transparency, and a framework for continuous improvement
• Drive standardization and innovation to ensure future fitness of the organization.

Qualifications

• PhD or Master in Biostatistics, Statistics, Computer Science or a related field.
• A minimum of 15 years of experience working in the pharmaceutical, biotech, or CRO industry. A minimum of five years of leadership experience is strongly preferred.
• Significant oncology is experience is required.

Knowledge and Skills

• Track record of leading and overseeing global regulatory submissions in oncology
• Proficiency in statistical programming languages (e.g., SAS, R).
• Solid experience with reporting process, regulatory requirements, and software development life cycle.
• Strong leadership, interpersonal, and organizational skills, and ability to work within cross-functional teams
• Strong communication skills with ability to align the company on complex technical decisions.
• Proven experience in developing and leading high-performing teams.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues, and positively influence the team.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.