Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking an Associate Director, Statistical Programming. This position is responsible for performing the programming and statistical analyses necessary to analyze the results of clinical trials and related research activities. This position also contributes to the interpretation of the results of these analyses and provides statistical input for the reporting of the results. This person will also validate/crosscheck the relevance and accuracy of the statistical programs and the resulting Tables, Listings and Graphs (TLGs) developed by external Clinical Research Organizations (CROs) and participate in the development and maintenance of SAS macro library and safety database.
- Manages, reviews and / or executes 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.
- Leads global submission activities including cross company projects. Acts as a programming functional and technical expert to support submission strategy planning, regulatory communication.
- Manages CROs and contractors with regarding the compliance, deliverable qualities, timelines and budgets
- Participates in recruitment activities; Supports planning and directing work between internal resources and external vendors
- Able to produces timely statistical analyses of clinical and related data analysis per protocols and SAPs. Able to develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.
- Participates in the development and maintenance of internal SAS macro library and safety database.
- Provides statistical input for Statistical Analysis Plans (SAPs), publication activities, scientific presentations, and promotional material.
- Participates in the review of Case Report Forms (CRFs), CRF annotations, SAPs, and TLGs shells and TLGs.
- Participates in study team meetings as an Indication lead of the statistical programming function. Communicates statistical issues and acts as a statistical/programming resource to the development teams.
- Participates in the assessment, selection, and evaluation of CROs.
- Able to Create/Review derived dataset specifications and the related analysis datasets.
- Able to develop training guidelines related to statistical programming.
- 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.
- The position will be a remote position
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel may be required (~10%)