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Manager, Statistical Programming (Must require skills Line management, SDTM

Ergomed · Bangalore

📅 07/08/2026
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Company DescriptionMedicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner. We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.Job DescriptionThe Manager, Statistical Programming provides leadership and oversight for a global team of Statistical Programmers, ensuring the delivery of high-quality work that meets established timelines, budget expectations, industry standards, and internal processes. This role is accountable for managing and coordinating statistical programming activities across clinical development projects, including the creation and review of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs). In addition, the role is responsible for coaching, mentoring, and developing team members, fostering a culture of continuous learning, collaboration, and excellence.The Manager also contributes to departmental process improvements, standards development, and strategic initiatives that enhance operational efficiency and quality. Through effective leadership and partnership, this position supports the achievement of company, departmental, and functional objectives while driving successful project outcomes.Role and ResponsibilitiesManages a team of Statistical ProgrammersOversees project activity including aspects of quality, budget, and timelinesEnsures that all work for relevant studies is resourced appropriatelyProvides continual feedback and development support for all team membersSupports the growth and development of all members of the Statistical Programming functionParticipates in relevant performance management activities including review, development, and problem mitigationParticipates in the review and assessment of new team membersDevelops best practices to achieve Statistical Programming department goalsContributes to the review and development of controlled documentsMaintains robust knowledge of industry expectations and best practicesIdentifies any potential issues within the department and works with senior leadership to resolve themOversees a portfolio of studies with Statistical Programming activities to ensure all work is completed on time, within budget, and meeting or exceeding client expectations.Supports Operational ExcellenceActs as a senior reviewer and support for Statistical Programming work performedAs needed, leads and/or supports the creation of client deliverables with an emphasis on large, complex, or other high priority opportunitiesSupports the creation of templates, reusable text, or other work products that may support future work by improving quality and/or reducing cost/effort.Represents Statistical Programming to internal senior leadership and/or to external organizations (e.g., audits, bid defenses, conferences, etc.) regarding topics of performance, quality, goals, and other relevant topics.Supports the Director, Biostatistics on topics related to corporate goals, department development, industry trends, and other relevant topics.In addition to the above:Leads special projects or initiatives to help improve the efficiency, profitability, or operational excellence of the department. Develops clear goals and expectations for the teamAids in the development of the Statistical Programming team including hiring strategiesResponsible for project financials of studies lead by direct reportsPlan and coordinate the statistical programming in the support of integration work for regulatory submissionsInteracts with applicable internal teams to provide a high standard of consultation on issues related to the statistical programming of clinical trials in a variety of therapeutic areasSupport the Biostatistics Director or equivalent with departmental wide resource forecasts and planningSupport the Biostatistics Director or equivalent in .
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