HR Lead at SigTuple
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SigTuple - Senior Biostatistician (5-12 yrs)
At SigTuple, we are seeking Senior Biostatisticians to lead and analyze all parts of any clinical study, and provide planning on multiple clinical studies internally and externally including tracking project activities and project time management. As a senior bio-statistician you will provide statistical input into other disciplines- activities and participate in interdepartmental processes, provide technical solutions and advice to scientists and medical professionals on statistical processes, supervise project activities, and be responsible for the development of Statistical Analysis Plans including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and mockups.
- Ensure mechanisms are in place to maintain flow of appropriate information between disciplines on project team.
- Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of SigTuple's signatories.
- Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project.
- Statistical analysis of clinical trial data and related decision making.
- Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.
- Provide statistical input into design/review of format of CRFs.
- Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
- Determine documentation requirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
- Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Data Listings, statistical reports, Clinical Study Reports.
- Contribute to review and amendment of departmental processes and supporting documentation.
- B-Stat, M-Stat or PhD in statistics, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)
- 5+ years of experience in the application of statistics to clinical trials
- The ability to work on tight deadlines while maintaining high standards.
- Proficiency in using a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis.
- A good knowledge of the overall Clinical Trial, Clinical Development process and regulatory requirements.
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
- Ability to explain statistical concepts to non-statisticians.
- Ability to adhere to strict guidelines and codes of practice.
- Interpersonal and effective communication skills; cooperative, team-oriented and proactive
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