Sr Biostatistician统计师

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 3-4年工作经验 | 硕士

2020-05-20发布

招聘人数:若干

100000-250000元/年

申请职位

职位信息

Position Summary Senior Biostatistician will work independently on clinical trial related tasks. The daily work includes protocol design/review, study design verification, CRF design review, leading data review meeting and mentor staff on the SAP generation. Ensure quality process and key delivery. Take lead or play oversight role in assigned projects. Key Responsibilities - Contribute to Study design. - Review statistical sections of protocol. - Review CRF and database design. - Perform sample size and power calculations. - Write statistical sections of protocol. - Plans and leads Data Review Meetings. - Provide statistical expertise for complex analyses. - Drafts SAP (including TLFs). - Consults on statistical modeling and analyses. - Reviews and mentors other staff on the writing of SAPs and TLFs to ensure scientific integrity. - Mentors staff on statistical design and application to therapeutic areas. - Serves as senior statistical reviewer on entire development programs. - Participates in client interactions/ assist to manage client expectations. - Conduct statistical programming for effective analysis and outcome verification. - Provides specifications for analysis datasets and TLFs. - Implements SAS to check datasets, verifies algorithms, outputs ? Generation and review of TLFs for delivery. - Oversees teams in providing specifications for analysis datasets and TLFs. - Provides sufficient detail for statistical analyses and models. - Supervise, mentors, and trains new or junior staff in statistical or programming skill development. Professional Experience & Education Requirement - Masters in biostatistics, statistics, mathematics, or related field, with at least 4 years working experience in biopharmaceutical or CRO or similar environment; Or Ph. D. degree (preferred) Have proven extensive biostatistics experience. Key Competency Requirement - Knowledge of various therapeutic areas or considered a go-to person in one area. - Ability to explain complex statistical concepts to statisticians and non-statisticians. - Familiar with GCP/ICH guidelines &CFDA guidelines. - Solid knowledge about CDISC CDASH/SDTM/ADAM data standard. - Ability to communicate effectively with sponsors regarding statistical issues. - Supports and conducts training on the best application on industry user groups. - Oversees efforts to implement ISS/ISE and CDISC initiatives. - High proficiency in SAS,R/S-Plus or JMP skill. 备注: ‘职位月薪’ 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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