The Manager, Biostatistics provides management oversight of personnel and project level activities within the Biostatistics team and serves as an individual contributor. S/he will have extensive knowledge of clinical trials and will advise on all stages of the clinical trial work from study design, study endpoints, statistical methods, protocol development, SAP development, specification writing, data review, and CSR completion. This individual has the ability to design studies and perform statistical analyses. In addition, S/he will work closely with the Leadership of Biostatistics and Programming to provide oversight of the Biostatisticians, project manage biostatistics deliverables, as well as serve as the team lead on clinical study projects. S/he ensures statistical analyses are conducted with the highest level of clinical ethics, scientific integrity and data.
Principle Responsibilities: (essential job duties and responsibilities)
- Manages Biostatisticians as appropriate, including but not limited to resource planning, recruitment, performance management, progressive discipline, and training need identification.
- Ensures that the Biostatistics team meets timelines and provides high quality results
- Sets challenging, achievable goals for direct reports which contribute to department objectives and supports efforts to achieve those goals. Provides motivating, timely performance feedback to direct reports on a routine basis as well as for formal performance reviews
- Acts as a lead Biostatistician on company sponsored studies assuming all lead responsibilities including but not limited to overseeing execution of statistical analyses as per SAP, vendor management, directing statistical programming, mentoring junior statisticians, update status of project to management on a regular basis, and escalate issues in a timely manner.
- Develops technically sound, highly innovative statistical solutions to complex analytical problems.
- Produces or oversees the production of protocol development (study design, endpoint selection, sample size calculations, statistical methods section) and detailed statistical analysis plans that lead to comprehensive statistical/clinical study reports suitable for regulatory submissions.
- Stays current with statistical methodology in clinical trial design and analysis.
- Assists management with review and statistical methodology for investigator-initiated studies, trial reports and publications.
- Performs statistical analyses of clinical and non-clinical data as necessary for management decisions, regulatory requests for information, commercial support, pre-clinical and publication support.
- Applies extensive programming expertise in SAS® and other analytical software (i.e. nQuery) to clinical trial applications and other non-trial research data.
- Serves as a liaison between Biostatistics team and other departments/teams (e.g., Project Medical/Safety Leader, Data Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Research and Development) on statistical issues, guiding and contributing for the development of new products
- Establishes, maintains, and ensures compliance with Standard Operating Procedures, Quality Procedures, and Work Instructions.
- Maintain knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Engage in process improvement initiative(s)
- Perform activities and tasks as directed by supervisor
- Bachelors or master’s degree in Statistics, Biostatistics or related field with experience in Clinical Research setting. Minimum of 8 yrs. for BS, 5 yrs. for MS
- Proficiency in complex statistical methods and statistical packages used within SAS.
- Must possess strong interpersonal and communication skills, effectively communicating both verbally and in written format.
- Successful track record leading project teams
- Minimum 6 years experience in clinical trials
- Minimum 1-2 years of management experience
- Demonstrated supervisory and/or management skills
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Ability to organize, lead, and motivate teams
- A team player with strong project management and leadership skills
- Self-directed and comfortable working in teams with the ability to work and operate independently
- Advanced knowledge with FDA and ICH regulations and guidelines, medical terminology and clinical trial methodologies
- Preferred knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements
- Good communication skills
- SAS server-based knowledge.