Senior Manager – Associate Director – Director, Statistical Programming

Role Overview

• Serve as the lead statistical programmer for clinical studies, providing technical leadership and project management oversight for all programming activities
• Oversee vendors that develop, validate, and maintain SAS programs and associated documentation to generate high-quality regulatory-compliant deliverables, including SDTM and ADaM datasets, define.xml files, reviewer’s guides, tables, listings, and figures (TLFs)
• Collaborate with biostatisticians and cross-functional study teams to develop and ensure implementation of Statistical Analysis Plans (SAPs) and programming specifications
• Oversee the creation, review, and maintenance of programming plans, dataset specifications, TLF specifications, review guides, validation documentation, and other required study documentation
• Provide expert-level support and oversight for CDISC implementation, including SDTM and ADaM standards, ensuring compliance with regulatory requirements and industry best practices
• Oversee conformance checks using Pinnacle 21 and other validation tools; identify, troubleshoot, and resolve data and submission issues to ensure submission-ready deliverables
• Generate ad hoc analyses and reports to support Clinical Development, Medical Affairs, Drug Safety, and other functional areas
• Support interim analyses, database locks, clinical study reports, publications, and global regulatory submissions
• Actively participate in development of exploratory analyses, including defining questions of interest and suggesting solutions
• Oversee and manage CRO programming activities, including review, quality control, and acceptance of outsourced deliverables; provide guidance and solutions for programming-related issues
• Contribute to the development, implementation, and continuous improvement of departmental standards, SOPs, work instructions, and programming best practices
• Ensure all statistical programming deliverables comply with company standards, regulatory requirements, and applicable industry guidelines
• Collaborate effectively with internal teams, external vendors, and regulatory partners while communicating project status, risks, and solutions
• Maintain complete and accurate programming records and documentation in accordance with company procedures and submission requirements
• Perform other statistical programming and biometrics-related duties as assigned

Requirements

• Graduate degree required in Statistics, Biostatistics or closely related fields
• Minimum of 3-5 years of experience in pharmaceutical/biotech with experience programming in a clinical trial environment to support regulatory submissions
• Expert level of SAS programming skills; knowledge of some additional programming languages (e.g. R, Python, Spotfire) a plus
• Expert knowledge regarding clinical trial design, data collection/cleaning, regulatory requirements and their relationship with data analysis
• Familiar with ICH guidelines, possess advanced knowledge of submission requirements and standards
• Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM, and ability to oversee vendors creating CDISC outputs
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests; ability to investigate data and add value through exploratory analyses with minimal prompting
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
• Strong organizational and multitasking skills
• Excellent communication and interpersonal skills

Tech Stack

• Python

Benefits

• 90% employer-covered benefits
• Flexible PTO
• A very generous holiday schedule that includes a week off in August and time off around the winter holidays
• A well-stocked kitchen with snacks and beverages
• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match
• The comprehensive wellness program includes medical, dental, vision, and LTD coverage