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

ERGOMED

Manager leading Statistical Programming for Ergomed, a CRO advancing rare disease and oncology therapies. Overseeing SDTM, ADaM, TLFs, teams, budgets, timelines, and regulatory submission support.

Posted 8/6/2026full-timeRemote • 🇮🇳 IndiaSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Statistical Programming, including the creation and review of SDTM and ADaM datasets, while effectively managing teams and projects to meet clinical development goals. Possesses strong leadership skills to mentor team members and drive departmental efficiency and operational excellence.

Highest-signal resume keywords

Statistical Programming ManagementSAS ProgrammingR ProgrammingSDTM Dataset CreationADaM Dataset Creation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingSDTM Dataset CreationADaM Dataset CreationTables, Listings, and Figures (TLFs)Project ManagementPerformance ManagementBudget ManagementRegulatory Submission IntegrationClinical Trials KnowledgeBest Practices Development

Soft Skills

CoachingMentoringTeam LeadershipCommunicationProblem-Solving

Industry Keywords

Clinical DevelopmentCRO ExperienceBiostatisticsStatistical Programming Best PracticesKPI Management

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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