Principal Statistical Programmer

  • Contract
  • Remote

SimulStat

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Remote, 6-month contract with potential to extend long term

Principal Statistical Programmer (SAS)

Our client is dedicated to developing breakthrough therapies for neurodegenerative diseases through a deep commitment to degeneration biology and principles of translational medicine. We are seeking to recruit an experienced principal statistical programmer. The candidate will have the opportunity to help shape the client’s data and programming infrastructure, gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in the field of neurodegeneration.

The ideal candidate will have extensive experience supporting drug development and clinical study projects; will have excellent statistical programming and problem-solving skills; and will be able to function as an individual contributor. As a member of the Biometrics team, the candidate will work closely with colleagues from biostatistics, clinical science, and other development functions, as well as external clinical research organizations.

Primary Responsibilities

  • Represent data science on project and study teams. Lead statistical programming deliverables including: creation of datasets, data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.); providing input for study data standardization plan, statistical analysis plans, study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management on case report form design, data review plans, and external data transfer specifications; collaboration with the study team to review data and manage timelines; oversight of Biometrics CRO deliverables.
  • Provide technical leadership in designing, developing, and validating of clinical trial data for regulatory submissions in CDISC standards.
  • Oversee, review, and/or execute statistical programming deliverables related to study monitoring, clinical study reports, integrated analysis (ISS, ISC and ISE), and regulatory query responses
  • Develop and manage reusable code for interactive data visualization, exploratory analysis, and statistical summaries.
  • Lead and/or support the Biometrics Team in efforts to build, maintain, and continuously improve an SAS/R infrastructure that is suitable for regulatory submission work.
  • Work with the Biometrics team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.
  • Effectively interact with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.
  • Identify, develop, and maintain statistical programming standards, processes, and SOPs

Requirements

  • Must Have
  • At a minimum, a bachelor’s degree in Statistics, Biostatistics, Data Science, Mathematics, or related field.
  • 6-10 years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
  • Demonstrated ability to effectively lead projects and collaborate cross-functionally.
  • Extensive applied experience of CDISC standards (SDTM and ADaM)
  • Prior experience of leading one or more global regulatory submissions (NDA/BLA/MAA) in CDISC data standards.
  • Advance knowledge of Regulatory & Compliance requirements for Biometrics function.
  • Exceptional SAS programming skills and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
  • Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.
  • Experience applying software development concepts, and proficiency in using Git/GitHub for collaboration and versioning of operational, robust, and well documented code.
  • Able to work in a Linux/Unix environment (including shell scripting).

 

  • Preferred
  • Prior work experience with pharmacokinetic data, the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux, and git), experience with Amazon Web Services and cloud infrastructure. 

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