Associate Director, Statistical Programming

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as an Associate Director, Statistical Programming. This role involves managing and executing statistical programming deliverables for clinical trials, leading global submission activities, and managing CROs. You will contribute to the interpretation of analysis results and provide statistical input for reporting. The position requires strong SAS programming skills and experience in clinical data analysis within a biotech/pharmaceutical or CRO environment. This remote position offers a competitive salary, equity, and a comprehensive benefits package including unlimited paid time off and parental leave.

Requirements

• Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 10 years in statistics or statistical programming in a biotech/pharmaceutical or CRO environment
• Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 12 years in statistics or statistical programming in a biotech/pharmaceutical or CRO environment
• Excellent SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems
• Experience in lead programming activities involving CDISC SDTM, ADaM, eSub
• Applied knowledge of clinical data analysis and reporting process as it relates to drug development
• Excellent interpersonal and communication skills
• Good organizational skills with the ability to adapt and adjust to changing priorities
• Experience with CRO oversight
• Regulatory submission experiences. Have lead programming activities involving CDISC SDTM, ADaM, eSub

Responsibilities

• Manage, review and/or execute statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies
• Lead global submission activities including cross company projects. Act as a programming functional and technical expert to support submission strategy planning, regulatory communication
• Manage CROs and contractors with regarding the compliance, deliverable qualities, timelines and budgets
• Participate in recruitment activities; Support planning and directing work between internal resources and external vendors
• Produce timely statistical analyses of clinical and related data analysis per protocols and SAPs. Develop statistical programs and produce programmed outputs used to create integrated scientific reports for clinical trial results
• Participate in the development and maintenance of internal SAS macro library and safety database
• Provide statistical input for Statistical Analysis Plans (SAPs), publication activities, scientific presentations, and promotional material
• Participate in the review of Case Report Forms (CRFs), CRF annotations, SAPs, and TLGs shells and TLGs
• Participate in study team meetings as an Indication lead of the statistical programming function. Communicate statistical issues and act as a statistical/programming resource to the development teams
• Participate in the assessment, selection, and evaluation of CROs
• Create/Review derived dataset specifications and the related analysis datasets
• Develop training guidelines related to statistical programming

Benefits

• Remote work
• Medical, dental, vision
• 401k
• Unlimited paid time off
• Parental leave
• Equity