Sr. Analyst, Statistical Programming

About This Role

The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high‑quality, submission‑ready statistical outputs with some supervision. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.

You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is often the sole functional representative. You will help to implement the Data Strategy, provide input to the Data Strategy Lead and DM lead on the strategic direction of the study to ensure appropriate statistical programming standards implementation and serve as reference for the study to the Data Sharing representative.

You will develop and implement standard programming practices while also ensuring that they are employed across a study. You will collaborate with technical programming on tools and process improvement for Statistical Programming.

• Lead, coordinate and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
• Author CDISC (Clinical Data Interchange Standards Consortium) ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination. Work with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
• Manage the end‑to‑end programming of deliverables from CRF (Case Report Form) collections through electronic submission including preparation of electronic submission components; work with SMEs (Subject Matter Experts) to ensure compliance to submission standards.
• Serve as the Statistical Programming Lead to achieve milestones for a study; collaborate with PL and/or manager on issues or resource needs.
• Verify program consistency and usage of data, analysis and submission standards within a study in consultation with data standards, statistical submissions management and the data strategy plan.
• Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

You are a Senior Analyst with strong statistical programming skills who pays close attention to detail and has the proven ability to manage competing priorities.

• Bachelor’s degree required.
• 5+ years relevant work experience within an organization with a focus on data management and analysis.
• 5+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO.
• 5+ years relevant industry experience.
• 5+ years clinical trial experience.
• 3+ years clinical database experience.
• CDISC and/or submissions experience.
• Knowledge of drug development process and clinical trials.
• Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.
• Some familiarity with UNIX as well as software development packages (R, imaging and genomics software packages).

• Bachelor’s degree required;
  Masters or PhD in Statistics or Mathematics preferred.
• 7+ years relevant work experience within an organization with a focus on data management and analysis.
• 7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO.
• 7+ years relevant industry experience.
• 7+ years clinical trial experience.
• 5+ years clinical database experience.
• CDISC and/or submissions experience.
• Knowledge of drug development process and clinical trials.
• Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW…