Senior Statistical Programmer

See Yourself at Telix

The Senior Statistical Programmer will work as a part of the Telix’s Clinical Operations team to assist in developing and maintaining clinical trial data. This role will work to develop statistical programming standards and ensure that the organization is up to date and in line with pharmaceutical industry standards.

Key Accountabilities

• Review protocols, statistical analysis plans, and other study related documents to support accurate data mapping and statistical analysis. Review specification for different datasets, SDTM/ADAM. Develop SAS programs to generate/validate variables and datasets.
• Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
• Work collaboratively with data standardization subject matter experts, clinicians, biostatisticians and other Medidata AI groups to assist in evaluating the accuracy of integrated historical data.
• Perform statistical analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming.
• Develop TLGs for each study level trial and perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
• Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
• Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.
• May represent the company in interactions with clinical trial sponsors regarding statistical programming projects and relevant businesses.
• Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.

Education and Experience

• Master’s degree or equivalent, in Statistics, Biostatistics or Mathematics required
• 6+ years of statistical analysis and/or SAS programming experience in the Pharmaceutical & Biotech industry. Experience with additional programming languages a plus.
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
• Regulatory submissions experience utilizing define.xml and other submission documents. Understanding of FDA guidelines.
• Strong SAS analysis and reporting skills. Solid experience implementing CDISC Standards (SDTM/ADaM) including writing/reviewing ADaM specifications; programming and validation including efficacy domains. Proficiency in SAS MACRO development.
• Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.
• Ability to research clinical trials in clinicaltrials.gov, Trialtrove, PubMed and other references to explore study characteristics.
• Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience.
• Prefer experience in Oncology trials.