Senior/Principal Statistical Programmer

About the Role

We are seeking a Senior/Principal Statistical Programmer, to join our team. The Statistical Programmer will provide expert-level hands-on principal programming support and technical leadership to develop, maintain, validate, and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. The ability to work independently and expert SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT programming experience is required. This position reports to the Senior Director, Statistical Programming and will be based out of Boston, MA, USA in our Needham office. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Responsibilities

• Manage programming activities on project or study level, including managing CROs to ensure deliverables are accurate and compliant.
• Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, eSUB packages, and documenting production and validation programs.
• Work with Biostatistics and other functions for the development and maintenance of the data review and reporting tools, e.g., aCRF, SAP, and mock review, and any other statistical applications as appropriate.
• Work with CRO counterpart on project timeline management; oversee and provide input on statistical programming activities, ensure timely and quality delivery.
• Follow good programming practices, create, and validate global SAS macros and utilities to automate standard and frequent tasks, enhance quality and efficiency.
• Apply programming skills to support statistical analysis, clinical reporting, regulatory submissions, Ad-Hoc/post-Hoc requests, and scientific publications.
• Support the development of statistical programming SOPs and standard processes as needed.
• Other duties as assigned.

Qualifications

• A minimum of a bachelor’s degree in a scientific, computer science or related field, training in statistics preferred.
• A minimum of 5 years (8 years for principal) of statistical programming experience in a pharma, biotech, or CRO environment.
• Knowledge of multiple phases of clinical development and experience in using SAS for clinical trials TFL report and integrated analysis for regulatory submissions is a must.
• Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define xml.
• Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT; advanced SAS programming ability to implement standard statistical analyses; experience in developing SAS macros to standardize the workflow and internal processes.
• Experience in CNS, pediatric rare disease area preferred.
• Experience in CRO management.
• Strong communication, leadership and interpersonal skills required.
• An equivalent combination of education and experience may be considered. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.