Senior Manager, Statistical Programming

🔥 2 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 19%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Lead and oversee a global team of Statistical Programmers • Manage and coordinate statistical programming activities across clinical development projects • Oversee creation and review of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs) • Ensure study work is appropriately resourced and completed on time, within budget, and to client expectations • Provide continual feedback, coaching, mentoring, and development support to team members • Participate in performance management and assessment of new team members • Develop best practices, controlled documents, templates, reusable text, and other work products • Identify departmental issues and work with senior leadership to resolve them • Act as a senior reviewer and provide support for Statistical Programming work • Lead or support client deliverables for large, complex, or high-priority opportunities • Represent Statistical Programming to internal senior leadership and external organizations, including audits, bid defenses, and conferences • Support the Director, Biostatistics on corporate goals, department development, industry trends, and related topics • Lead special projects and initiatives improving departmental efficiency, profitability, and operational excellence • Develop team goals and expectations and support hiring strategies • Manage project financials for studies led by direct reports • Plan and coordinate statistical programming for regulatory submission integration work • Consult with internal teams on statistical programming for clinical trials across therapeutic areas • Support resource forecasts, planning, metrics, and KPIs

🎯 Requirements

• Bachelor’s degree or higher in mathematics, statistics, biostatistics, computer science, or another related discipline • 10+ years of experience in Statistical Programming • Experience with SAS and R • CRO experience preferred • Knowledge of industry expectations and best practices • Ability to manage statistical programming projects, including quality, budgets, timelines, and resourcing • Ability to support regulatory submission integration work • Ability to provide consultation on statistical programming for clinical trials • Ability to support resource forecasting, planning, metrics, and KPIs

🏖️ Benefits

• Remote work opportunity • Work-life balance • Career growth and development opportunities • Collaborative international team environment • Coaching, mentoring, and development support • Continuous learning opportunities

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