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