Senior Biostatistical Programming Manager

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $151.838 - $205.427 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 0%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 5 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.

Candidatar-se

Encontrar Vagas Remotas Similares

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

• Work in Amgen's Biosimilar organization supporting multiple products • Represent the product programming function and participate in multidisciplinary project team meetings • Collaborate closely with Biosimilar Statisticians and other functional team members • Coordinate and oversee development of dataset specifications and implementation of TLGs according to statistical analysis plans, work practices, and project timelines with CROs • Review and approve analysis dataset specifications • Review or contribute to data management plans, database development, and edit checks plans • Contribute to and review statistical analysis plans and results in IBs, protocols, clinical study reports, integrated summaries, publications, and other documents • Provide support and input in protocol development, case report form design, and data collection • Ensure statistical outputs, datasets, and related documentation are archived according to company standards • Anticipate and communicate resource and quality issues affecting deliverables or timelines • Participate in review of CRO policies, SOPs, and controlled document development • Participate in recruitment of programming staff within the Biosimilar organization • Recommend program-level consistency and submission readiness, including data standards • Work with CRO and Amgen teams to assemble submission data packages • Lead or contribute to technical solutions for executing CRO programs on Amgen systems and perform ad-hoc analyses supporting submissions and publications • Lead or contribute to process improvement and operational efficiency • Adhere to Amgen policies, SOPs, and standards applicable to biosimilar development

🎯 Requisitos

• BA/BSc or higher degree in quantitative or scientific subjects • At least 8 years of relevant statistical programming experience in a clinical development environment • Excellent oral and written English communication skills • Experience working effectively in a cross-functional team environment • Advanced SAS programming skills in processing clinical data (SAS - BASE, STAT, Macro and Graph) • Working knowledge of latest CDISC SDTM, ADaM and Define-XML standards • Ability to lead and manage programmers in the successful and timely completion of all programming activities for a project • Ability to effectively perform complex statistical programming and related tasks • MSc or higher degree in quantitative or scientific subjects preferred • Familiarity with other programming languages (e.g. Java, R) • In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL • Regulatory submissions experience • Thorough understanding and experience with data quality and compliance checks, e.g., Pinnacle21 • Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies • Prior staff development and project management experience • Ability to train others

🏖️ 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 • 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 support

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo