Senior Manager, Statistical Programming

October 27

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Immunovant

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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. • Able to produce timely statistical analyses of clinical and related data analysis per protocols and SAPs. • Able to develop 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 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. • Able to create/review derived dataset specifications and the related analysis datasets. • Able to develop 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 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.

🏖️ Benefits

• full range of medical, dental, vision, 401k, and other benefits • unlimited paid time off • parental leave