统计编程经理（需具备技能：团队管理、SDTM数据集、ADaM数据集、TLFs）
Manager, Statistical Programming (Must require skills: Line management, SDTM datasets, ADaM datasets, TLFs)
医学在这里不断前进，你也将如此。
Ergomed 是一家专注于罕见病和特定肿瘤适应症的临床研究专业机构。我们专注于最复杂的试验，这些研究中，经验、判断力和严谨的运营责任能带来最大的影响。我们与中小型生物科技公司合作，推动有前景的疗法通过早期阶段开发，使它们更快地到达患者手中。
我们有意选择复杂的工作。罕见病和肿瘤试验具有真正的运营风险，而我们的员工是降低风险的专家，在保护时间表、数据质量和站点及患者的体验的同时，做到这一点。这是一项要求高且有意义的工作，这里没有人会忘记患者不能等待。
这就是为什么文化对我们而言和能力一样重要。我们建立了一个协作、国际化的团队，人们分享想法，发展职业生涯，并被信任尽早承担职责。我们拥有遍布北美、南美、欧洲、亚洲和澳大利亚的同事，我们重视团队合作、灵活性和对工作与生活平衡的真正承诺，因为优秀的科学来自感到支持的人们。
如果你希望有目标地工作，拥有迅速产生影响的敏捷性，以及一个既关心工作本身也关心背后的人的团队，我们很期待收到你的来信。
统计编程经理负责领导和监督全球统计程序员团队，确保交付符合既定时间表、预算期望、行业标准和内部流程的高质量工作。该职位负责管理并协调临床开发项目中的统计编程活动，包括SDTM数据集、ADaM数据集、表格、列表和图形（TLFs）的创建和审查。此外，该职位还负责指导、辅导和发展团队成员，培养持续学习、协作和卓越的文化。
统计编程经理还参与部门流程改进、标准制定和战略计划，以提高运营效率和质量。通过有效的领导和合作，该职位支持公司、部门和职能目标的实现，同时推动成功的项目成果。
职位和职责
· 管理统计程序员团队
· 监督项目活动，包括质量、预算和时间等方面
查看英文原文
Medicine 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.
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, with 10+ 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’ll join 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 the outcome, because someone is waiting on it.
· Agility and responsiveness: we move quickly, because patients 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.
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