Manager, Statistical Programming (Must require skills: SDTM datasets, ADaM datasets, TLFs)

Ergomed Group; India; On-site; INR 300,000 - 540,000; Full time

Benefits offered by this job

Remote work

Job summary

Ergomed Group, a specialist clinical research organization, is seeking a Manager, Statistical Programming to lead a global team. You will oversee SDTM/ADaM dataset creation, Tables, Listings, and Figures (TLFs), ensure timelines and budgets, and mentor team members across regions.

This role emphasizes collaboration, quality, and efficiency, with opportunities to contribute to process improvements, client deliverables, and regulatory submissions.

Qualifications

• Experience leading a statistical programming team in clinical research.
• Hands-on expertise with SDTM and ADaM datasets.
• Ability to manage Tables, Listings, and Figures (TLFs) for regulatory submissions.
• Strong mentoring and team development skills.

Responsibilities

• Lead a global team of Statistical Programmers to deliver high-quality work on time and within budget.
• Oversee creation and review of SDTM/ADaM datasets, TLFs, and associated specifications.
• Develop and enforce best practices, templates, and documentation for Regulatory Science deliverables.
• Collaborate with Biostatistics, Data Management, and Project teams to ensure study success.

Skills

SDTM datasets

ADaM datasets

TLFs

Education

Bachelor’s degree in mathematics, statistics, biostatistics, computer science, or related disciplines

Tools

SAS

R

Job description

Manager, Statistical Programming (Must require skills: SDTM datasets, ADaM datasets, TLFs)

• Full-time

Medicine moves forward here. So willyou.

Ergomed is a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,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, dataqualityand 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 theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported.

If you wantworkwith 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.

The 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 Responsibilities

• Manages a team of Statistical Programmers
  • Oversees project activity including aspects of quality, budget, and timelines
  • Ensures that all work for relevant studies is resourced appropriately
  • Provides continual feedback and development support for all team members
  • Supports the growth and development of all members of the Statistical Programming function
  • Participates in relevant performance management activities including review, development, and problem mitigation
  • Participates in the review and assessment of new team members
• Develops best practices to achieve Statistical Programming department goals
  • Contributes to the review and development of controlled documents
  • Maintains robust knowledge of industry expectations and best practices
  • Identifies any potential issues within the department and works with senior leadership to resolve them
  • Oversees 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 Excellence
  • Acts as a senior reviewer and support for Statistical Programming work performed
  • As needed, leads and/or supports the creation of client deliverables with an emphasis on large, complex, or other high priority opportunities
  • Supports 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 team
• Aids in the development of the Statistical Programming team including hiring strategies
• Responsible for project financials of studies lead by direct reports
• Plan and coordinate the statistical programming in the support of integration work for regulatory submissions
• Interacts 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 areas
• Support the Biostatistics Director or equivalent with departmental wide resource forecasts and planning
• Support the Biostatistics Director or equivalent in maintaining metrics and KPIs.

Bachelor’s degree (or Higher) in mathematics, statistics, biostatistics, computer science, or other related disciplines, with10+ years’ experience in Statistical Programming (SAS and R), preferably in a CRO.

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality:we hold ourselves to the standard patients deserve.
• Integrity and trust:we do the right thing, especially when it is hard.
• Drive and passion:we care about theoutcome, becausesomeone is waitingonit.
• Agility and responsiveness:we movequickly, becausepatients cannot wait.
• Belonging:everyone is welcome, and every voice counts.
• Collaborative partnerships:we go further by going together.

We look forward to welcoming your application.

#LI Remote