高级/资深(R 程序员)
Senior/ Principal (R Programmer)
**高级程序员**
**职责**
高级程序员的职责是为统计和编程部门在多个项目、客户和治疗领域提供编程支持。高级程序员也可能承担监督职责(例如直线管理和/或项目管理)。
**主要职责**
以下列出的工作任务概述了该职位的范围。这些任务的应用可能根据当前的业务需求而有所不同。
**技术方面:**
• 审查临床试验文件,包括方案、SAP、CRF、CSR
• 编写、审查并批准研究TFL模板和数据集规范
• 编写、验证并记录数据集、TFL和宏的程序,应用良好的编程实践
• 识别数据问题和异常值
• 完成、审查并批准CDISC验证工具报告
• 识别数据和标准问题,并适当解决或升级
• 关注新兴标准及其对正在进行和未来计划中的试验的影响
• 保持对R语言的熟练程度并关注其发展
• 维护研究主文件文档和其他需要审计准备的文档
**人员管理:**
• 管理统计学家、程序员和其他技术人员。对直接下属的整体表现负责
• 提供指导和辅导以实现“卓越”。直接负责员工的职业发展,并确保下属获得适当的培训以完成日常任务
• 面试并有效招聘和融入新员工
• 提供编程技术领导力和指导
**项目管理:**
• 监督关键客户项目/组合。
o 在客户账户和项目中担任Veramed项目经理
o 维护项目计划
o 主动管理资源、范围变更和风险
o 管理项目在预算内交付
o 管理客户期望和问题解决
**其他方面:**
• 有效领导内部和客户的研讨、项目和跨职能团队会议
• 在内部和客户会议上进行研究更新汇报
• 与团队成员和同事分享科学、技术和实际知识
• 按照适用的法律法规、公司政策、程序和培训要求全面执行工作
• 与内部和客户团队成员建立有效的协作关系
• 确保经验在整个项目中得到共享
查看英文原文
**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._