Associate Director Statistical Programmer

Overview

• Lead statistical programming activities at study or project levels, ensuring high-quality deliverables and adherence to regulatory standards.
• Utilize SAS software to create macros, listings, tabulations, and graphical summaries for clinical data analysis.
• Develop datasets in standard formats such as SDTM and ADaM, ensuring compliance with CDISC standards.
• Collaborate with biostatisticians and clinical data management teams to establish data collection and reporting standards.
• Provide programming QC oversight for CRO deliverables, ensuring accuracy and consistency in outputs.
• Troubleshoot technical and project issues, contributing to infrastructure development within the department.
• Assist in training new employees and contractors on macros, study specifics, and departmental programming conventions.
• Ensure adherence to FDA regulations, company SOPs, and department guidelines for programming activities.
• Support ad-hoc requests and manage multiple tasks simultaneously to meet business needs.

Key Responsibilities & Duties

• Maintain and enhance existing macros, providing training and documentation for macro usage.
• Develop new global macros and standard programs following Software Development Lifecycle (SDLC) methodologies.
• Coordinate data transfers and output deliveries with clinical data management staff and biostatisticians.
• Identify resource needs for projects and oversee statistical programmers' work as required.
• Ensure accurate programming outputs through defensive programming and thorough result checking.
• Oversee CROs' development of datasets, ensuring clear documentation of processes followed.
• Adhere to regulatory and company standards in training records, guidelines, and SOPs.
• Produce study datasets and programs that align with CDISC standards.
• Communicate effectively with external departments and groups to ensure project timelines are met.

Job Requirements

• Bachelor's degree in a related discipline with 11 years of relevant experience, or advanced degrees with equivalent experience.
• Proficiency in SAS/Base, SAS/Stat, SAS/Macros, and familiarity with UNIX and CDISC standards.
• Experience in pharmaceutical or biotech programming, with oncology clinical trials and NDA submission experience as a plus.
• Strong analytical and business communication skills, with the ability to manage complex tasks effectively.
• Extensive knowledge of technical principles, theories, concepts, and techniques relevant to statistical programming.
• Ability to work on multiple tasks simultaneously, prioritize effectively, and meet business needs.
• Demonstrated leadership and management skills, guiding teams to achieve organizational goals.
• Commitment to adhering to regulatory standards and company policies in all programming activities.
• Experience in training and mentoring team members to ensure high-quality deliverables.