Senior Biostatistical Programming Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $151.8k - $205.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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