Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting
Assesses the quality and consistency of analysis data and performs cross-study analyses
Uses internal macros or writes SAS® macros to automate study deliverables
Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies
Has sufficient understanding to follow an analysis plan and provide programming support for study deliverables
Assists in the review of GSI Policies, SOPs and other controlled documents
Provides input to and participates in Programming and Clinical Data Science meetings
Contributes to the continuous improvement of Programming Environment
Demonstrates SAS programming proficiency
Generates the production of statistical analysis datasets and outputs (e.g., tables, figures, and listings) for study reports and integrated summaries
Has knowledge of clinical trial study design and electronic data submission requirements
Assists with study and systems audits, and responds to audit questions and findings
Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies and helps define the data set

Master’s and 2 years of relevant experience OR Bachelor’s and 4 years of relevant experience
Degree in Biostatistics/Computer Science or equivalent (preferred)
5+ years of pharmaceutical/CRO experience (preferred)
Prior experience in oncology, hematology, cell therapy strongly preferred
Knowledge of long term follow up trial knowledge strongly preferred
Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.) (preferred)
In-depth understanding of clinical programming and/or statistical programming processes and standards
In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
Extensive experience with statistical programming using the SAS and R software including development and use of SAS Macros, R Packages
Experience with development of CDISC standardized ADaM datasets and specifications
Advanced knowledge in SDTM domains
Proven experience in leading programming activities
Excellent interpersonal, communication, problem solving, and analytical skills.
Willing to handle multiple projects and ad-hoc tasks

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

Statistical Programmer II

Key skills