Senior Manager, Statistical Programming

The role

This person will perform programming and statistical analyses to analyze clinical trial results and related research. They will also validate outputs from external CROs and contribute to the development of SAS macro libraries and safety databases.

What you will do

• Interacts with CROs to ensure statistical analyses and outputs are accurate and consistent.
• Produces timely statistical analyses of clinical and related data per protocols and SAPs.
• Develops statistical programs and produces programmed outputs for integrated scientific reports.
• Participates in the development and maintenance of internal SAS macro library and safety database.
• Provides statistical input for SAPs, publication activities, scientific presentations and promotional material.
• Participates in the review of CRFs, CRF annotations, SAPs, and TLG shells and TLGs.
• Participates in study team meetings as a representative of the statistical programming function.
• 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.

Required qualifications

• 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
• 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
• Excellent SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS).
• 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.
• Medical
• Dental
• Vision
• 401k
• Unlimited paid time off
• Parental leave

About the company

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. The company is developing innovative therapies for a range of debilitating autoimmune diseases.