Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs.
The Role:
Immunovant is seeking a Senior Manager, 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 and cross-check 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.
Key Responsibilities:
- Interacts 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. Works with vendor staff to characterize and resolve issues related to data analysis.
- Produces timely statistical analyses of clinical and related data per protocols and SAPs. 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 TLG shells and TLGs.
- Participates in study team meetings as a representative 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.
- Creates and reviews derived dataset specifications and the related analysis datasets.
- Develops training guidelines related to statistical programming.
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 leading programming activities involving CDISC SDTM, ADaM, and eSubmission (e.g., define.xml, ADRG/SDRG).
- 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.
Work Environment:
- The position will be remote and headquarters based in Durham, NC.
- Dynamic, interactive, fast-paced, and entrepreneurial environment.
- Domestic or international travel may be required (~10%).
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.
Skills Required
- Master's degree in Statistics, Mathematics, Computer Science, or another quantitative sciences discipline, plus at least 7 years of statistics or statistical programming experience in a biotech, pharmaceutical, or CRO environment
- Bachelor's degree in Statistics, Mathematics, Computer Science, or another quantitative sciences discipline, plus at least 10 years of statistics or statistical programming experience in a biotech, pharmaceutical, or CRO environment
- Excellent SAS programming skills, including Base SAS, SAS/STAT, SAS/GRAPH, SAS macros, and ODS
- Good understanding of database systems
- Experience leading programming activities involving CDISC SDTM, ADaM, and eSubmission standards, including define.xml, ADRG, and SDRG
- Applied knowledge of clinical data analysis and reporting processes related to drug development
- Excellent interpersonal and communication skills
- Good organizational skills and ability to adapt to changing priorities
- Experience working with contract research organizations
- NDA and MAA submission experience
What We Do
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. For U.S. residents only.
