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.
- 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。