Senior Manager, Statistical Programming

🕒 October 15

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $175k - $195k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Immunovant

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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.

📋 Description

• Perform programming and statistical analyses necessary to analyze clinical trial and related research results • Contribute to interpretation of analysis results and provide statistical input for reporting • Validate and cross-check external CRO statistical programs and resulting Tables, Listings and Graphs (TLGs) • Participate in development and maintenance of the SAS macro library and safety database • Interact with CROs to ensure analyses and outputs are accurate and consistent with agreed deliverables • Characterize and resolve data analysis issues with vendor staff • Produce statistical analyses according to protocols and Statistical Analysis Plans (SAPs) • Develop statistical programs and outputs for integrated scientific reports • Provide statistical input for SAPs, publications, scientific presentations, and promotional material • Review Case Report Forms (CRFs), CRF annotations, SAPs, TLG shells, and TLGs • Represent statistical programming in study team meetings and communicate statistical issues to development teams • Participate in CRO assessment, selection, and evaluation • Create and review derived dataset specifications and related analysis datasets • Develop statistical programming training guidelines

🎯 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

🏖️ Benefits

• Equity and other forms of compensation may be provided as part of a total compensation package • Medical benefits • Dental benefits • Vision benefits • 401k • Unlimited paid time off • Parental leave • Remote work • Dynamic, interactive, fast-paced, and entrepreneurial environment