The Biostatistics group supporting the Inflammatory/Immunology and Ophthalmology Therapeutic Focus areas is looking for a Biostatistician at the Manager level. The Manager assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area Lead Biostatistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases incumbent could serve as technical expert in a particular statistical area or application.
- With general guidance from senior departmental staff, assume leadership role for providing statistical support to one or more study teams on all relevant statistical matters. Act as direct liaison to the study team or provide guidance to a junior staff member filling this role. Provide leadership in development / design of one or more protocols for a specific project. Work with the clinical and regulatory functions to define study endpoints and perform relevant sample size calculations. Develop statistical analysis plan (SAP).
- Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables.
- Oversee execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR). Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results.
- Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or to independent monitoring committees. Review submission documents, such as IND, BLA, or CTD to insure statistical validity and accuracy.
- Collaborate with project team on the production of the clinical development plan (CDP). Work with senior departmental staff to develop statistical position on key study or project issues. May act as representative to extended project team.
- Provide significant input to Therapeutic Area Lead Biostatistician on project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.
- Active research interest in area related to clinical trial. Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.
- Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Leads by example and manages staff by commitment. Self directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required.
- Knowledge of pharmaceutical / biotech clinical development
- Ability to use statistical methods to assess/improve efficiency and effectiveness in drug development
- Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis
- Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines
- Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications
- Familiarity and practical experience in design, production, and use of submission-quality electronic datasets.
- Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses
- Strong communication skills, experience managing internal team and CROs
- Ability to organize, lead, and motivate teams
- SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
- Also acceptable – Ph.D. in statistics or related discipline with 6+ years of experience in the biotechnology, pharmaceutical or health related industry.
- May report to a Assoc. Director or above. Requires the ability to influence others to achieve results. May manage subordinates.
Type:DirectLocation:Tarrytown, NY, USA