Biotech/Pharmaceutical

Sr. Programming Tools and Applications Leader

Permanent

Penfield Search Partners

Contact: Linda Aronova –  laronova@penfieldsearch.com

Sr. Programming Tools and Applications Leader, Biostatistics and Programming, Remote US

Job description: In this role you will provide technical leadership, and project management skills, to oversee govern, maintain and validation, of several integrated standard SAS macro libraries, templates, and other submission tools with their related processes, used across biostatistics & programming (B&P) user community.

You will work in close collaboration with IT, B&P and User Champions as well as our Data Standard and Operations team (DSO) to address bugs, collect requirements and pain points, propose improvements, design, plan and document releases, test and deploy new/updated macros following our software development life cycle methodology.

You will also act as User Project Lead for our SCE

Reporting to the Global Head of Analytics and Reporting Tools (ART) you will join a team with broad skillset and experiences supporting a large number of transversal projects across B&P and beyond where you will bring your SAS expertise to support companywide initiatives with impact on our processes and our Metadata Assisted Programming initiative. You will also provide mentoring to the junior level staff with an emphasis on technical capabilities and deliver regular training sessions to our user community.

The ideal candidate is curious, possess good communication skills, is eager to learn and open to other data science programming languages such as R, Julia and Python while keeping up to date on the latest developments coming from SAS.

Major responsibilities include:

  • Lead the development, documentation, testing and deployment of our SAS statistical reporting tools, and associated standard template programs
  • Force of proposal to evolve/improve SAS applications (and associated template programs) Alert on resource availability as necessary
  • Follow-up the implementation of each release on time, as agreed when setting objectives
  • Provide User requirements
  • Manage a part of the PUMA Acceptance/Deploy phases (play the ASU role in PUMA methodology)
  • Facilitate the communication between dev team and B&P users to ensure timely clarification of issues and effective resolution on proposals for the evolution of tools and processes (Assist in early issue identification, facilitate issue resolution and notification)
  • Ensure a strong connection with ART development and Standard update
  • Application Governance lead
  • Work with B&P leadership and with Application Support User (ASU), SMEs to prioritize and build the roadmap for the yearly updates and maintenance of our SAS macro library and template programs (TPs) including validation and documentation.
  • Track and report on progress
  • Key contact with Digital and Business QA for the deployment of B&P maintained application following our GxP SOP
  • Collaborate with a network of WW user champions to ensure proper usage and timely user feedback, providing WW training/communication (e.g., newsletter, SharePoint, workshop, webinar, etc.) to
  • Bring expertise and knowledge to users and follow up on usage
  • Build an active network, motivate local user champions.
  • Keep users updated on related initiatives, new functionalities and processes
  • Identify business needs on continuous improvements (by using surveys or from experts)
  • Contribute to the documentation of tools and applications (e.g., user guide, conventions, etc.)Develop and maintain training materials (with the help of local user champions)

Qualifications:

  • A candidate with a master’s degree or a bachelor’s degree and 8+ years of programming experience processing clinical trial data in the pharmaceutical industry or CRO.
  • Excellent technical skills in statistical programming, with advanced knowledge in SAS on SAS Grid and SAS Viya.
  • Demonstrated experience and strength in developing, maintaining, and deploying statistical analysis and reporting tools / systems.
  • Demonstrated experience with Computer System validation
  • Proven experience in the development and execution of project charter, user requirements, functional and design specifications, validation plans, development, and implementation.
  • Excellent project management skills.
  • Ability to effectively organize and manage multiple assignments with challenging timelines.
  • Strong understanding of clinical trial data and the technical requirements of analysis and reporting in clinical trials.

Preferred Education/Experience:

  • A candidate with an advanced degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field, preferred
  • Experience with other programming languages such as R, Python, JavaScript, Julia, highly desired.
  • Good understanding of versioning using Git or GitLab and DevOps tools: Jira, Confluence
  • Demonstrated Knowledge of CDISC standards.
  • Good understanding of regulatory requirements concerning electronic submission.
  • Strong understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques and clinical trial principles).
  • Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation.
  • Strong problem-solving, root cause analysis skills.
  • Excellent verbal and written communication skills in a global environment.
  • Experience in collaboration with external partners and/or vendors.

Tagged as: Sr. Programming Tools and Applications Leader