Senior Manager, Statistical Programming

Summary

Join Immunovant, a clinical-stage immunology company, as a Senior Manager of Statistical Programming. This role involves performing statistical analyses of clinical trial data, interpreting results, and contributing to reports. You will validate analyses from external CROs, maintain SAS macro libraries, and provide statistical input for various documents. Collaboration with CROs and participation in study team meetings are key aspects of this position. The position is remote, with potential for limited travel. Compensation includes a competitive salary, equity, and a comprehensive benefits package.

Requirements

• Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 7 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 10 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 working with CROs
• NDA/MAA submission experience

Responsibilities

• Interact with Contract Research Organizations (CROs) involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables
• Work with vendor staff to characterize and resolve issues related to data analysis
• 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 a representative 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

• Full range of medical, dental, vision, 401k, and other benefits
• Unlimited paid time off
• Parental leave
• Equity and other forms of compensation may be provided as part of a total compensation package