长沙招聘

Primary Responsibilities
General
? Designs and plans statistical algorithms and code in conformance with a globally aligned Systems Development Life Cycle (SDLC) and programming standards, such as Pfizer clinical data standards, and are in compliance with relevant SOPs and the applicable regulatory guidelines for the assigned clinical development programs
? Ensures timely and quality programming documentation for inspection readiness
? Provides input into the design and development of project plans: provide planning, development and delivery of analyses, (tables, listings and figures) for use in scientific reports, clinical trial results, publications, regulatory response and commercialization
? Delivers according to the overall protocol timeline and quality goals through matrix communication within the Study Team
? Develops and maintains TA specific knowledge base for clinical programming practice and coordinates experience sharing across studies, e.g. best practices, lessons learnt, metrics of trends analysis, etc.
? Communicates effectively within the teams and functional lines
? Maintains responsibility and metrics on quality control process for CPW deliverables


Hands-on clinical programming responsibilities (Individual Contributor):
? Reviews and provides feedback on protocol, CRF, SAP and other study-related documents to ensure all programming requirements are met
? Contributes to the Study Reporting Plan (SRP) and related programming documentation to ensure programming completeness and accuracy
? Performs hands-on programming activities (generation and QC of tables/listings/figures/datasets) and provides technical expertise to support data reporting for clinical trials
? Provides programming algorithm support as needed
? Produces PK/PD analysis data files and data presentations according to corresponding processes and standard (PK/PD Programmer)


Study programming responsibilities (Lead Programmer):
? Serves as the primary clinical programming point of contact for study team
? Performs duties of a CPW Individual Contributor as needed
? Works under the guidance of Project Programming Lead to proactively plan, assess workload, establish timelines, and prioritize activities for the analysis and reporting of clinical study data.
? Co-leads (with Project Programming Lead) relevant study team meetings (e.g. BDR)
? Responsible for timely and quality programming documentation at study level, including programming plan, list of tables, table shell, QC plan, BDR issue log and other related programming documents
? Provides technical oversight and guidance to hands-on programmers in all the programming activities at study level
? Produces and tracks study level metrics to ensure that programming deliverables meet quality and speed targets

Project programming responsibilities (Project Programming Lead):
? Works directly with CROSLs/CPMs as the single point of contact for clinical programming at project level
? Performs duties of a lead programmer as needed
? Accountable for the implementation of clinical programming activities for studies and submissions related to project level
? Accountable for the consistent practices (standard, process and documentation) within a project and ensures lessons learnt in one study are shared across all studies within a project
? Accountable for timely and quality programming documentation within a project
? Actively oversees EPM project milestones and manages inconsistencies through networking with relevant CROSLs/CPMs to ensure milestones are achieved
? Helps CROSLs/CPMs to have direct access to the most relevant biometrics expertise at anytime
? Partners with PDL to ensure full biometrics availability at anytime during different study stages
? Serves as a contact for internal and external audits, as well as communicating with regulatory authorities with regard to clinical programming-related processes and activities at project level
? Accountable for timely reporting of relevant project metrics on quality, speed and compliance to programming TA lead and ensures timely cross-TA sharing for lesson learnt and accomplishment in CPW
? Ensures that programming activities are conducted in compliance with SOPs and relevant regulatory requirements


Training & Education Preferred:
? Minimum of Bachelor’s Degree or equivalent in statistics, computer science, mathematical science or related discipline; Master’s Degree preferred

Prior Experience Preferred
? Clinical Programming and industry experience in order to have a thorough understanding of the processes associated with clinical drug development and programming operations

Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
? Clinical Programming expertise









? Organizational skills




? Communication skills



? Project/process management


? Clinical development process





? Administrative excellence



? Clinical/Scientific aptitude



? Technology management







? Problem solving / Decision Making ? Extensive knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP
? Extensive knowledge of clinical programming processes and principles, including software development/validation, QC and definitions of specs
? Extensive knowledge of SAS and associated applications, including good coding practices

? Works independently. Receives instruction primarily on unusual situations
? Ability to organize tasks, time and priorities of self and others; ability to multi-task.

? Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally

? Ability to manage studies and processes to agreed quality and timelines

? Knowledge of the clinical development process, understand concepts and planning of Phase I-IV, regulatory reporting requirements, Submissions and Rapid Response.

? Attention to detail evident in a disciplined approach to document maintenance and management

? Understanding of scientific/clinical principles, and ability to work across different therapeutic areas

? Extensive knowledge/understanding of technologies to support data acquisition and data validation
? Extensive knowledge/understanding of tracking systems and document management systems; awareness of CFR 21 part 11.

? Ability to identify and evaluate multiple options to make decisions at a functional level, and make recommendations at a project team level, which have the potential to impact the delivery of the program/project and resource on the program/project.



Behavioral Competencies:
Competency Detail / Comments (specific skills, etc.)
? Collaborative, supportive



? Innovation





? Influencing





? Networking and Alliance Building


? Learning Organization




? Flexibility


? Tactical Thinking



? Teamwork








? Initiating and Implementing change





? Customer Focus ? Work successfully with others to ensure team effectiveness and demonstrate Pfizer values

? Explores, implements and utilizes novel, moderately complex methodologies; encourages and shares innovative approaches to build and maintain a competitive advantage

? Lobbies key internal and external stakeholders to ensure delivery of study goals
? Ability to influence and negotiate to achieve win-win solutions.

? Looks for opportunities for collaboration to help deliver study goals and acts upon them

? Contributes to a learning environment by sharing knowledge and best practice within and across study teams. Mentors other team members in core discipline.

? Responds positively and constructively to changing situations

? Develops and implements short- and mid-term study plans to deliver study team goals with limited support

? Ability to work independently and within a team; shows respect and support for all team members.
? Works collaboratively with group members and contributes to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line

? Advocates and encourages actions that improve existing approaches and systems.
? Proactively manages change by identifying opportunities and coaching self and others through the change

? Identifies and builds effective relationships with customers and other stakeholders

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。