EG-Statistical Programmer (职位编号：(J24401))社

面议

武汉市本科及以上4年及以上

发布时间：2023-09-06

职位描述

工作职责:
Position PurposeAccountable for the provision of standard and non-standard data sets, tables, listings and figures based on the protocol and SAP that are required for the study reports, submissions and product defense
Delivers according to the overall protocol timeline and quality goals through matrix communication within the Study Team
Ensures programming deliverables are reproducible, defendable and inspection ready at any time
Represents programming on study management team to communicate effectively within the teams and functional lines
Creates and maintains consistent, efficient and quality processes to meet timelines and deliverables
Champions operational excellence to provide continuous improvement of processes and sharing of best practices across TA’s
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
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 PreferredClinical Programming and industry experience in order to have a thorough understanding of the processes associated with clinical drug development and programming operations
任职资格:
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

其他要求

招聘人数：1人
职能类别：

公司介绍

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。