Senior Programmer I & II / Principal Programmer
**主要程序员****目的** 主编程序员的作用是为统计和编程部门提供各种项目，客户和治疗领域的编程支持。主编也可能担任监督角色 （例如线路管理和/或项目管理）. **关键责任**下列职位任务概述了职位范围。这些任务的应用根据当前业务需求可能会有所不同。**技术：** •执行临床试验文件审查，包括协议，SAPs,CRF,CSRs •作者，审核和批准研究 TFL 子和数据集规格 • 编写，验证和记录数据集，TFL 和宏观程序，采用良好的编程实践 •确定数据问题和异常值 •完成，审查和批准 CDISC 验证工具报告 •根据情况识别数据和标准问题并解决或升级 •了解新兴标准以及与正在进行的及未来计划试验相关的影响 •保持 R 方面的熟练知识和对发展意识 •保持研究主文件文档和其他需要审计的其他文件准备 **人员管理：** •统计师，程序员和其他技术人员线路管理。负责直接报告总体表现 • 提供教练和指导员工以实现卓越性。直接培养员工职业生涯，确保线条报告获得适当的培训来执行日常工作 • 面试并有效地参与新员工并集成他们 • 提供编程技术领导和辅导 **项目管理：** •监督关键客户项目/投资组合。o 担任客户账户和项目项目项目经理 o 维护项目计划 o 积极管理资源，范围变化和风险 o 管理项目到预算中的交付 o 管理客户期望和解决问题的问题 **一般：** •有效地领导内部和客户研究，项目和跨职业团队会议•在内部和客戶会议上提出学习更新•与团队内及同事分享科学，技术和实践知识•完全遵守适用的法律，法规，公司政策，程序和培训工作•建立与内部和客服团队成员的有效合作关系 •确保学到的经验得到共享
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**Principal Programmer**
**Purpose**
The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management).
**Key Responsibilities**
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
**Technical:**
• Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs
• Author, review and approve study TFL shells and dataset specifications
• Author, validate and document programs for datasets, TFLs and macros, applying good programming practice
• Identify data issues and outliers
• Complete, review and approve CDISC Validation tool reports
• Identify data and standards issues and resolve or escalate as appropriate
• Awareness of emerging standards and associated impact to ongoing and future planned trials
• Maintain proficiency in R and awareness of developments
• Maintain study master file documents and any other documents that are required to be audit ready
**People Management:**
• Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports
• Provide coaching and mentoring of staff to achieve “excellence”. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs
• Interview and effectively on-board and integrate new staff members
• Provide programming technical leadership and coaching
**Project Management:**
• Oversight of key client projects/portfolios.
o Being Veramed Project Manager on client accounts and projects
o Maintain the project plan
o Proactive management of resource, scope change and risks
o Manage the delivery of projects to budget
o Manage client expectations and issue resolution
**General:**
• Lead internal and client study, project and cross functional team meetings effectively
• Present study updates internally and at client meetings
• Share scientific, technical and practical knowledge within the team and with colleagues
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
• Build effective collaborative working relationships with internal and client team members
• Ensure learnings are shared across projects or studies
• Develop and provide internal technical training where appropriate
• Lead process improvement initiatives
**Minimum Qualification Requirements**
• BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
• At least 8 years of relevant industry experience
**Other Information/Additional Requirements**
• Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Proficiency in data handling using R
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Ability to work independently and as part of a team
• Ability to manage a portfolio of projects and/or people
**Senior Programmer**
**Purpose**
The role of the SeniorProgrammer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas.
**Key Responsibilities**
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
**Technical:**
• Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
• Author and review simple and complex study TFL shells
• Author and review simple and complex dataset standards
• Perform data checks and data exploration (e.g. using frequencies, histograms)
• Program and QC routine and ad hoc datasets and TFLs (in R) following specifications, applying good programming practice
• Complete and review CDISC Validation tool reports
• Ensure the appropriate standards are being applied and adhered to
• Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
• Review of project management related documents
• Maintain study master file documents and any other documents that are required to be audit ready
**Project Management:**
• Act as Lead Programmer and/or Veramed Project Manager for client projects and studies
• Maintain the project plan
• Proactive management of resource, scope change and risks
• Manage the delivery of projects to budget
• Manage client expectations and issue resolution
**General:**
• Lead internal and client study team meetings effectively
• Present study updates internally and at client meetings
• Share scientific, technical and practical knowledge within the team and with colleagues
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
• Build effective collaborative working relationships with internal and client team members
• Seek opportunities to develop innovative ideas, sharing when appropriate
• Line management or mentorship of more junior team members
• Contribution to development of internal training materials
• Contribution to internal process improvement initiatives
**Minimum Qualification Requirements**
• BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
• At least 4 years of relevant industry experience
**Other Information/Additional Requirements**
• Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Proficiency in data handling using R
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Ability to work independently and as part of a team
**_Veramed is a B Corp_** _accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability._
_As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment._