广州招聘

Position Summary
Manages the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials. Serve as a lead statistician on clinical studies and provide senior level statistical input to study activities and deliverables. Adherence to Angitia standards, and all applicable regulations and guidelines. Maintain the statistical and analytical integrity of clinical trials data analyzed by in-house resources or external vendors. Responsible for making recommendations with regards to the strategic aspects of clinical studies as well as oversight of biometrics activities.
This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities include, but are not limited to the following:
? Works on extremely complex problems in which analysis of situations for data requires an evaluation of intangible variables.
? Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
? Communicates with various internal and external audiences such as, scientists, engineers, clinicians, quality staff and partners as required.
? Acts as the lead statistician on clinical research projects and help with SAS programming.
? Provides strategic input on protocol design and clinical trial data analysis, develops statistical methodology sections of planned protocols, oversight of development of statistical analysis plans, programming support and of any outsourced biometric responsibilities.
? Provides the assistance in the generation of high-quality clinical trial data to aid in programmatic decision-making.
? Plays a statistical leadership role in the support of Regulatory filings and submissions.
? Contributes to the development of charters for DSMBs and Endpoint Adjudication Committees and may serve as a sponsor liaison with these committees.
? Prepares and provides written reports, presentations and publications as required. Collaborates with other functional lines including Regulatory, Clinical Sciences and Clinical Operations.
? Serves as point of contact for biometrics support provided by external vendor.
? Identifies, develops and delivers internal biometrics SOPs and training courses as required to provide effective biometrics support to customers.

Skills/Knowledge
? Previous experience working in a quality regulated environment with a thorough understanding of cGCPs is required.
? Must demonstrate sound knowledge of applied statistics and biostatistics and relevant experience; be able to apply judgment and professional expertise independently in the application of statistics to clinical trials.
? Previous experience designing and delivering presentations/trainings is required. Strong oral and written communication skills in English are required.
? Must be goal-oriented, quality-conscientious, and customer-focused.
? Experience working in a team-focused environment is preferred.
? Excellent computer skills are required. Must have a thorough understanding of SAS programming.
? Must be detail oriented. Must have an ability to create and manage internal and external technical and business relationships, representing biometrics in a highly professional manner.

Sr. Manager, Biometrics Requirements
Minimum Requirements – Education and Experience:
? Ph.D. in statistics or closely related discipline with a minimum of 3 years of experience in pharmaceutical and biotech industry.
OR
? Master's Degree in statistics or equivalent with a minimum of 6 years of experience in pharmaceutical and biotech industry.

AD, Biometrics Requirements
Minimum Requirements – Education and Experience:
? Ph.D. in statistics or closely related discipline with a minimum of 6 years of experience in pharmaceutical and biotech industry.
OR
? Master's Degree in statistics or equivalent with a minimum of 9 years of experience in pharmaceutical and biotech industry.
职能类别：
临床数据分析员
关键字：
生物数据统计临床生物统计生物统计

    安济盛生物医药技术（广州）有限公司地处广州科学城，是一家专注于骨骼肌肉关节等疾病的创新药物研发企业。安济盛生物医药技术（广州）有限公司的创始人及核心团队拥有多年在海外及国内大型跨国公司的药物研发和管理经验。公司拥有专业技能的新药靶标的研发团队，精通骨科疾病的病理生理学，运用遗传学和分子生物学前沿科学发现新的机理和信号传导通路及之间的互相作用，识别新的药物靶点，结合计算机辅助设计新型生物药物和小分子药物。公司产品的开发模式包括内部研发、与学术单位和全球业界研究机构建立外部合作等，服务于有需要的患者。欢迎有专业技能、积极乐观、上进和有团队合作精神的人士加入我们的团队。
我们的使命: 致力研发突破性创新药物，造福重症肌肉骨骼疾病患者！
Located in Guangzhou Science City, Angitia Biopharmaceuticals is an innovative biotech focusing on the discovery and development of novel drugs for serious bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines.？ The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.
Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.