Associate Director
Statistical Programming
Posted on 1/17/2023
Lyell Immunopharma

201-500 employees

Washington, USA
Experience Level
Desired Skills
Data Analysis
Google Cloud Platform
Software Engineering
  • This position requires extensive programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers
  • Bachelor's or master's degree in Statistics or Mathematics, Computer Sciences, IT, or related fields
  • Minimum of 6 years experience in the Pharmaceutical Industry, or relevant Regulatory environment
  • Thorough knowledge of CDISC SDTM, ADaM, Define.xml, and other industry standards, and ability to implement the standards
  • Strong knowledge of the clinical development process, GCP/ICH standards, and global regulatory submission requirements
  • Working knowledge of current regulations, familiarity with eCTD format and content of regulatory filings with prior experience filing a BLA/MAA/NDA
  • Current knowledge of technical and regulatory requirements relevant to the statistical programming role
  • Ability to apply programming expertise to problem-solving and troubleshooting for teams
  • Proven ability to operate with limited oversight
  • Ability to effectively manage multiple tasks and projects. Demonstrate planning and project management skills
  • Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures
  • Experience in working with an outsourced model
  • The Statistical Programming Associate Director is accountable for the quality, timely and efficient delivery of project programming work with good quality
  • Oversees and manages external vendors to ensure high-quality deliverables and manage timelines for the outsourced deliverables
  • Develops and validates standard department/generic macros and template programs
  • Effectively manages, develops, and reviews the analysis datasets, TLF's, and other deliverables as required
  • Provides expert-level hands-on support for the statistical programming deliverables including but not limited to the regulatory, publication, Adhoc requests, post-hoc, and exploratory data analyses
  • Leads and directs the full scope of project delivery and/or leads a technical project within the drug product/study/function
  • Leads Implementation of statistical programming aspects of the protocol or clinical development program
  • Leads or contributes to cross-functional administrative or process improvement initiative(s)
  • Participates in the development, maintenance, and adherence to departmental SOPs and Guidelines
  • Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function
  • Drives or supports standards development and implementation in statistical programming function
  • Manages and escalates risk in complicated situations within their study and/or projects
  • Provides input and/or drives improvement of processes and programming implementation
  • Maintains expertise in the latest industry and regulatory requirements to stay current
  • Manages and is willing to coach and mentor junior or contract programmers
  • Lead the projects for the programming deliverables and milestones from study start-up to regulatory submission
  • Work with the study, product, and biometrics team in goal and timeline setting
  • Develop or review technical programming specifications and programs, and generation of SDTM and ADaM datasets, Tables, Listings, and Graphs
  • Support, validate, and maintain programming infrastructure and standard department macros and template programs to ensure high-quality and efficient deliverables
  • Review documents for submission readiness and conformity to company and health authority guidelines eg SDSP, ADRG, cSDRG