A leading Pharmaceutical services company needs *Senior Biostatistician* in **Princeton, NJ**.
- Biostatistics lead for large global or other major projects.
- Provide statistical input into other disciplines' activities and participate in interdepartmental processes.
- Provision of technical solutions and advice to Client staff and to clients on statistical methodology and principles.
- Supervision of less-experienced biostatisticians within project activities.
- Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
- Training and development of less-experienced staff within the department.
- Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data-handling rules and mockups.
- Responsible for Biostatistics deliverables within assigned projects.
- 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.
- Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Client signatories.
- 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 Patient Data Listings, statistical reports, Clinical Study Reports.
- SAS programming and related activities for the presentation and analysis of clinical trial data.
- Contribute to review and amendment of departmental processes and supporting documentation.
- Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
- Provide support for special committees, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding.
- Contact with client across multiple disciplines.
- Contribute to proposal activities and client presentations.
Education/Qualifications - Five years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject.
- SAS proficiency including use of 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 process and of its application within Client Clinical Development.
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
- Ability to explain statistical concepts to non-statisticians.
- Supervisory and organizational skills.
Experience - Five years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject.