Sr Biostats Manager
Design and Execute Biostatistic Aspects of Clinical Studies in Japan
Lead Team of Statisticians on a Project Basis at a Rare Disease focused Pharma
- US Biopharma company specializing in rare diseases
- Responsible for directing the biostatistics activities in collaboration with HQ, from trial design, execution, analysis, and data interpretation.
- Serve as regional subject matter expert for specific programs and TAs and provides leadership to support all clinical studies, regulatory submissions, and publications for the program or therapeutic area.
Participate in development of clinical study protocols, including experimental design, specification of analysis endpoints, determination of sample size, and specification of methods of statistical analysis.
Participate in the design of case report forms and reviews data validation specifications and other data management documentation associated with clinical study database development.
Develop, review and approve statistical analysis plans.
Research, develop and implement statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements.
Design the layout and content of tables, figures, and listings in accordance with statistical analysis plans.
Participate in regulatory submission planning, including data submission strategies and the creation of integrated summaries.
Represent company in discussions and meetings with regulatory agencies.
Plays a key role in the development of biostatistics processes and procedures, including the writing and review of department standard operating procedures.
- Ideally MS or PhD in Statistics, or equivalent amount of experience the pharmaceutical industry including design, analysis, and reporting of clinical studies.
- Significant experience with regulatory submissions and interactions with regulatory agencies.
- Extensive experience with the design, analysis, and reporting of Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting.
- Demonstrated leadership skills as biostatistics lead on multiple clinical programs.
- Hands-on experience with developing detailed statistical analysis plans and designing tables, figures, and listings for clinical study reports.
- Knowledge of current topics and issues related to the design and analysis of clinical studies, including adaptive designs, multiplicity, handling of missing data, and sensitivity analyses.
- Strong oral and written communication, as well as problem-solving skills, are essential; ability to proactively identify issues and determine appropriate solutions to complex problems.
- Excellent working knowledge of the SAS software package; ability to communicate effectively with SAS programmers, review SAS output, and write SAS code as needed.
- Strong working knowledge of current regulatory requirements related to the submission of clinical study data and statistical programs.
- Experience in the development of integrated summaries of safety and efficacy. Demonstrated expertise in implementation of CDISC standards applicable to regulatory submissions.
- Ability to handle multiple projects at one time and direct resources appropriately to address frequent changes in priorities.
- Fluent English and Japanese skills
- Opportunity to work closely with patients suffering from rare diseases
- Contribute to the approval of innovative new drugs in unmet medical needs areas