生物统计师

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 5-7年工作经验 | 硕士

2020-10-17发布

招聘人数:1人

100000-300000元/年

申请职位

职位信息

Position Summary Lead and contribute to clinical trial and its related tasks for projects with certain complex. The daily work includes protocol design/review, study design verification, CRF design review, leading data review meeting, SAP development, and mentor staff on the SAP generation or relevant statistical support. He/she will lead key client interactions, drive meetings for the statistical part, help to allocate resources, and work cross-functionally. Key Responsibilities - Lead study design 1.Take lead and review statistical sections of protocol 2.Review CRF and database design 3.Perform sample size and power calculations, and conduct quality control process 4.Write statistical sections of protocol 5.Plan and leads Data Review Meetings 6.Provide statistical expertise for complex analyses 7.Supervise, mentor, and train new staff in statistical skills - Drafts SAP (including TLFs) - Consult on statistical modeling and analyses - Review and mentor other staff on the writing of SAPs and TLFs to ensure scientific integrity - Mentor staff on statistical design and application to therapeutic areas - Serve as senior statistical reviewer on entire development programs - Lead key client interactions and effectively influence client - Accurately forecast project resource requirements and help to allocate resources - Produce internal statistical/programming best practice templates - Conduct programming to support sophisticated analysis 1.Generation and review of TLFs for delivery 2.Oversee teams in providing specifications for analysis datasets and TLFs 3.Provide sufficient detail for statistical analyses and models - Provide supervision of staff in their development of programming, statistical analysis. SAP development, etc. - Lead projects and facilitate project meetings as a key member; Collaborate with clinical and relevant functions for project key milestone delivery - Extensive exposure in business development support, company key initiatives, external meetings - Act as the go-to-person based on own expertise in biostatistics methodology, technology or specific therapeutic areas - Contribute to company major projects or initiatives as a key resource Requirements - Master Degree in biostatistics, statistics, mathematics, or related field with proven extensive practical experience. Ph.D. will be a plus. - Experience in biopharmaceutical companies or CRO, with lead statistician experience and solid therapeutic area knowledge - Knowledge in various therapeutic areas or considered an expert in one specific area - Ability to explain complex statistical concepts to statisticians and non-statisticians - Familiar with GCP/ICH guidelines, And CFDA guidelines - Extensive knowledge and expertise in CDISC CDASH/SDTM/ADAM data standard - Ability to communicate with sponsors regarding statistical issues - Capable to conduct training regarding the best application to industry user groups - Solid experience in implementation of ISS/ISE and CDISC initiatives. - Strong SAS, R/S-Plus or JMP skills 备注: ‘职位年薪’ 仅供参考,具体薪资和福利将根据候选人经验和能力综合评定。

联系方式

上班地址:上海市浦东新区祥科路298号佑越国际3楼301-305

缔脉生物医药科技(上海)有限公司


•民营公司

• 少于50人

• 制药/生物工程

缔脉生物医药科技(上海)有限公司是一家临床合同研究组织(CRO),旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务,以我们专业能力、全球经验、先进技术和创新方法确保临床试验符合科学规范和满足法规和监管要求。我们希望推动国内临床开发水平和技能的不断提升从而促进中国创新药物走向全球,同时我们也希望以创新致力于提高临床试验的规划和执行效率,从而最终增大客户药物和医疗器械的成功几率。缔脉聚集了大批具有国际视野的、在临床试验方面具有丰富经验的专业人才,我们的主营业务包括专家咨询、临床试验运营、生物统计与编程、数据管理、药物安全与警戒、临床科学与医学事务、质量保证、稽查及核查准备、法规事务和策略等。
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