Medpace - Cincinnati, OH
posted 5 months ago
About the position
Medpace, Inc. is seeking qualified candidates for multiple Biostatistician II openings at its Cincinnati, OH location. As a Biostatistician II, you will lead the biostatistics activities for one or more clinical trial projects, ensuring that all work, including that of your team, is completed within defined time frames and meets appropriate quality levels. You will be responsible for balancing concurrent tasks and priorities while applying advanced statistical methods and your knowledge of the pharmaceutical industry. This role requires a strong understanding of regulatory requirements and guidelines for drug development, as well as the ability to design phase I-IV clinical trials. In addition to leading projects, you will present the biostatistics function at conferences, external non-study meetings, and bid defense meetings. You will also supervise a team of statisticians, ensuring that they are aligned with project goals and timelines. The position allows for remote work approximately 40% of the time, providing flexibility in your work environment. This role is critical in supporting the mission of Medpace to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. You will leverage local regulatory and therapeutic expertise across various therapeutic areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.
Responsibilities
- Lead the Biostatistics activities for one or more clinical trial projects
- Ensure all work (including work of team where responsible) is completed within defined time frames to appropriate quality levels and balance concurrent tasks and priorities
- Apply advanced statistical methods and knowledge of the pharmaceutical industry
- Apply regulatory requirements/guidelines for drug development
- Design phase I-IV clinical trials
- Present Biostatistics function at conferences, external non-study meetings, bid defense meetings
- Supervise Statisticians (15-2041)
Requirements
- PhD degree in Biostatistics, Statistics, or related field (foreign equivalent accepted)
- 1 year of experience as a Biostatistician or related
- 1 year of experience with pharmaceutical clinical trial experience
- Experience in clinical development plan preparation
- Experience in study protocol development
- Knowledge of industry and regulatory submission practices, protocol designs and terminology
- Statistical analysis plan generation
- Advanced SAS statistical analysis skills in Pharmaceutics/Biotech/CRO clinical trials
- Knowledge of regulatory requirements and guidelines for drug development
- Familiarity with CDISC SDTM/ADaM requirements
- Understanding of clinical trial data management terminologies/processes
Benefits
- Competitive PTO packages, starting at 20+ days
- Flexible work hours
- Discounted tuition for UC online programs
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with local nonprofit organizations
- Competitive compensation and benefits package
- Structured career paths with opportunities for professional growth
- Partnership and discount with onsite childcare
- Discounts on local sports games, local fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants
