The purpose of this position is to provide innovative statistical expertise for supporting medical safety or observational research by:
- Providing statistical leadership in identifying and implementing innovative methodologies for integrated analyses of safety or observational research.
- Providing strategic statistical input to integrated analyses of safety or observational research for clinical development, post-marketing surveillance, regulatory submissions and publications.
- Independently representing Safety Statistics in interactions with global PV function and other functions for process development and improvement.
- Monitoring and implementing advances in statistical methodology for medical safety or observational research, and promoting use of innovative methodologies.
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Independently represent Safety Statistics on global teams and projects in support of medical safety and observational studies for multiple compounds.
- Provide strategic statistical input to integrated analyses of safety or observational research for clinical development, post-marketing surveillance, regulatory submissions and publications.
- Provide statistical leadership in the development of statistical analysis plans, regulatory submission documents or publications, ensuring accurate and statistically valid deliverables for multiple compounds.
- Oversee all statistical and programming activities for medical safety or observational research for assigned compounds, including planning, data preparation or integration, table/listing/graph (TLG) production, and result interpretation.
- Provide oversight of vendor evaluation/selection and statistical and programming activities of external vendors to ensure quality and timeliness.
- Collaborates with other functions in research and implementation of advanced statistical methodologies for drug safety or observational research. Ensures that statistical methodologies are acceptable to regulatory agencies.
- Identify and interact with internal and external statistical experts for issue resolution related to medical safety or observational research.
- Provides leadership in development of innovative solutions to meet new challenges in drug safety (e.g., benefit-risk assessment) or observational research (e.g., OMOP initiatives). Drives development/selection and implementation of analytical tools for drug safety or observational research.
- Leverage scientific expertise for strategic statistical leadership by providing recommendations to management on challenging issues related data preparation/integration, statistical analysis and result interpretation.
- Monitor and implement advances in statistical methodology for medical safety or observational research, and promoting use of innovative methodologies for assigned compounds.
- Ensures compliance of function with Takeda SOPs, standards and all applicable regulations.
- PhD or MS in statistics, biostatistics, epidemiology, or equivalent.
- 8+ years of experience for PhD or 10+ years of experience for MS in the pharmaceutical industry, clinical or observational research.
- Expert knowledge of integrated analyses of safety or methodology of observational studies.
- Active in statistical/pharmaceutical professional organizations at regional or national level.
- Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to medical safety or observational research.
- Experience in playing a leading role in contributing to critical publications, regulatory requests or submissions.
- Excellent oral and written communications skills.
- Good statistical programming skills, and good knowledge of programming with respect to more complex statistical methods (eg, simulations).
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to sit and stand for long periods of time.
- Carrying, handling and reaching for objects.
- Ability to lift and carry over 25 pounds.
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
- Access to transportation to attend various meetings held in proximity to the Takeda offices.
- Able to fly to various meetings at investigator, vendor or regulatory agency sites.
- Some international travel may be required.
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