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Company

Immunovant · 2 days ago

Associate Director, Statistical Programming

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$180K/yr - $190K/yr

10+ years exp

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BiotechnologyPharmaceutical

Hiring Manager

Mohammad Ouranus

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Responsibilities

Manages, reviews and / or executes statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies.

Leads global submission activities including cross company projects. Acts as a programming functional and technical expert to support submission strategy planning, regulatory communication.

Manages CROs and contractors with regarding the compliance, deliverable qualities, timelines and budgets.

Participates in recruitment activities; Supports planning and directing work between internal resources and external vendors.

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 an Indication lead 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 analysisCDISC SDTMADaMStatistical programmingClinical data analysisRegulatory submissionsCRO oversight

Required

Master’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.

Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 12 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 with CRO oversight.

Regulatory submission experiences. Have lead programming activities involving CDISC SDTM, ADaM, eSub.