Immunovant · 3 days ago

Senior Manager, Statistical Programming

United States

Full-time

Remote

Senior Level

$160K/yr - $175K/yr

7+ years exp

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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.

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 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.

Qualification

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SAS programmingStatistical analysisClinical data analysisCDISC SDTMADaMNDA/MAA submissionCROsTraining guidelines developmentDatabase systems understanding

Required

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.