Associate Director, Statistical Programming

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY
The role of the Associate Director, Statistical Programming is to provide functional expertise and
leadership to clinical project teams. This includes leading statistical programming teams, establishing and maintaining the Statistical Programming function, qualifying an in-house statistical computing environment, and developing and maintaining SOPs, processes, and tools (e.g., macros). The Associate Director will also conduct hands-on work for these deliverables. Additional responsibilities include determining resource needs and overseeing the performance of contract programmers, Contract Research Organizations, and other vendors. The department’s deliverables include CDISC (SDTM and ADaM) data sets, tables, figures, and listings (TFLs) for clinical study reports (CSRs), development safety update reports (DSURs), investigator brochures, exploratory analyses and outputs for publications and internal data exploration, and listings and other deliverables to assist with data cleaning and review.

In close collaboration with the Director of Statistical Programming, statisticians, data managers, and clinicians, the Associate Director will ensure that statistical analyses supporting decision-making, publications, study reports, and regulatory submissions are delivered expeditiously and at a consistently high quality. This is a hybrid role that will require 3 days in the office (2 core days and 1 flex day). #LIHybrid

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provides comprehensive programming leadership and support to complex clinical project teams
  and vendors, including deployment of programming strategies, standards, specifications and
  programmed analysis to comply with regulatory requirements


• Oversee, manage, and/or perform internal statistical programming activities including:
  
  
  
  • Data validation and consistency checks and data listings
  
  
  • Planned TFLs for Clinical Study Reports (CSRs), Development Safety Update Reports
    (DSURs), Investigator Brochures (IBs), etc.
  
  
  • Exploratory analyses for publications, regulatory responses, and internal decision making
  
  
  
  


• Establish and maintain processes, tools, and standards relating to the production of all programmed deliverables (e.g. CDISC-compliant data sets and TFLs and data packages for regulatory submissions)


• Manage and mentor contract statistical programmers and CROs


• Develop processes and tools to drive efficiency and quality


• Work with data manages and statisticians and study team members to determine project needs and priorities

REQUIREMENTS

Education

• Bachelor’s or Master’s degree or equivalent in a technical discipline such as Mathematics, Statistics, Computer Science or Life Sciences

Experience

• At least 8 years of experience with SAS® programming in the pharmaceutical, biotech, or CRO industry


• Advanced SAS programming skills including SAS/BASE, SAS/Macro, SAS/SQL and plotting procedures


• Advanced knowledge and understanding of CDISC (SDTM, ADaM, define.xml) standards and implementations


• Excellent written and verbal communication skills


• A proven ability to solve problems working both independently and in teams


• Experience with alternative programming and mark-up languages (e.g. R, Python, XML) and/or data structures (e.g. XML, JSON) is desirable, but not essential

Travel

• Up to 20% travel

The target salary range for this full-time role is $187,000 - $235,400 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.