Biostatistical Programming Manager

🕒 Junho 23

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $130.000 - $140.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Provide rapid response statistical programming support for urgent internal and external requests • Serve as a lead programmer for studies and projects, including Data Access Plan activities, unblinding efforts, and special projects • Deliver hands-on programming support for SDTM, ADaM, Tables, Listings, and Figures, and other study and regulatory submission deliverables • Oversee execution and quality of projects managed by FSP partners according to Amgen’s Global Statistical Programming Quality Oversight Plan • Ensure FSP and in-house programming deliverables meet quality, compliance, timeline, and productivity expectations • Mitigate at-risk projects through technical expertise, programming support, and operational guidance • Contribute to training material development and delivery for internal teams and FSP partners • Provide guidance and technical consultancy on Amgen processes, tools, and utilities • Lead or contribute to continuous improvement and cross-functional initiatives, including inspection readiness, process improvement, innovation, and training • Contribute to performance metrics development, data collection, and reporting • Review project documentation, including specifications, issue logs, and deliverable status, for accuracy and completeness • Primarily support programs within the Obesity Therapeutic Area and collaborate closely with cross-functional teams

🎯 Requisitos

• Doctorate degree OR Master’s degree and 2 years of statistical programming experience OR Bachelor’s degree and 4 years of statistical programming experience OR Associate’s degree and 8 years of statistical programming experience OR High school diploma / GED and 10 years of statistical programming experience • 6+ years of statistical programming in biopharmaceutical industry • Regulatory submission experience • Strong hands-on SAS programming expertise including SAS Base, Macro, SQL, SAS/Graph and Stat packages • Experience with R programming for clinical trial analyses, data manipulation, reporting and visualization preferred • Familiarity with additional programming languages and tools such as Python preferred • Hands-on experience developing and validating SDTM, ADaM datasets, and TFLs • Thorough understanding of clinical trial processes from data collection through analysis and reporting • Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions • Strong understanding of data standards and compliance checks including Pinnacle 21 • Experience providing quality oversight for outsourced and internal programming deliverables • Ability to troubleshoot complex technical issues and turnaround at-risk projects • Experience working in a globally dispersed team on Phase 1-4 clinical trials • Experience supporting clinical development programs within the Obesity Therapeutic Area preferred • Understanding of obesity clinical endpoints, data standards, and regulatory considerations highly desirable • Excellent oral and written English communication skills; strong collaboration, negotiation, and organizational skills

🏖️ Benefícios

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance