Manager, Statistical Programming – Line Management, SDTM Datasets, ADaM Datasets, TLFs

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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

• Manage a team of Statistical Programmers • Oversee project quality, budgets, timelines, and resourcing • Coordinate statistical programming activities across clinical development projects • Oversee creation and review of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs) • Provide 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, and reusable work products • Maintain knowledge of industry expectations and best practices • Identify departmental issues and work with senior leadership on resolutions • Oversee a portfolio of studies and ensure delivery on time, within budget, and to client expectations • Act as a senior reviewer and support Statistical Programming work • Lead or support creation of complex or high-priority client deliverables • Represent Statistical Programming to internal leadership and external organizations, including audits, bid defenses, and conferences • Support the Director, Biostatistics with corporate goals, department development, industry trends, resource forecasting, planning, metrics, and KPIs • Lead special projects to improve 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

🎯 Requirements

• Bachelor’s degree or higher in mathematics, statistics, biostatistics, computer science, or a related discipline • 10+ years of experience in Statistical Programming • Experience with SAS and R • CRO experience preferred • Line management experience • Experience creating and reviewing SDTM datasets • Experience creating and reviewing ADaM datasets • Experience with Tables, Listings, and Figures (TLFs) • Knowledge of clinical development projects and statistical programming for clinical trials • Knowledge of industry expectations and best practices

🏖️ Benefits

• Remote work • Work-life balance • Career growth opportunities • Collaborative international team environment • Supportive culture • Opportunity to contribute to meaningful clinical research • Coaching, mentoring, and development support