Biostatistical Programming Manager

🕒 vor 9 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $130.000 - $140.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Amgen

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1980

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen ist ein weltweit führendes Unternehmen in der Biotechnologie, das sich auf die Entwicklung und Vermarktung innovativer Arzneimittel aus lebenden Zellen konzentriert. Das Unternehmen hat zum Ziel, schwere Krankheiten zu behandeln, wobei oft Krankheiten im Fokus stehen, für die es nur begrenzte therapeutische Möglichkeiten gibt. Amgen legt großen Wert auf wissenschaftliche Innovation und ist der ethischen Forschung, der Patientensicherheit und der ökologischen Nachhaltigkeit verpflichtet. Es ist aktiv in klinischen Studien engagiert und bekannt für seine Beiträge in den Bereichen Krebsbehandlung und Adipositas-Management unter anderem.

Beschreibung

• Provide rapid response statistical programming support for urgent internal and external requests • Serve as a lead programmer for studies and projects, such as Data Access Plan (DAP) activities, unblinding efforts, and special projects • Deliver hands-on programming support for SDTM, ADaM, Tables, Listings, and Figures (TFLs), and other study and regulatory submission deliverables as needed • Oversee the execution and quality of projects managed by our FSP partners per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP) • Ensure that FSP and in-house programming deliverables meet quality, compliance, timeline, and productivity expectations • Mitigate at-risk projects by providing technical expertise, programming support, and operational guidance • Contribute to training material development and delivery to internal teams and FSP partners • Provide guidance and technical consultancy to study programming team on Amgen processes, tools, and utilities • Lead/contribute to GSP continuous improvement iniatives and support cross-functional initiatives including inspection readiness, process improvement, innovation, and training activities • Contribute to programming team performance metrics development, data collection, and reporting • Review project documentation such as specifications, issue logs, deliverable status for accuracy and completeness

🎯 Anforderungen

• 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 is highly desirable • Excellent oral and written English communication skills; strong collaboration, negotiation, and organizational skills.

🏖️ Vorteile

• 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, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.