Senior Principal Biostatistician providing statistical expertise across therapeutic areas in clinical development. Collaborating with study teams and overseeing analysis plans for vital projects.
About the role
- Clinical Scientist executing and supporting clinical trials at Oruka Therapeutics. Collaborating with teams to ensure high-quality data collection and analysis for chronic skin disease treatments.
Responsibilities
- Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
- Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
- Perform data review, reconciliation and standardization to ensure high quality outputs
- Reviews clinical data to support in the assessment of the safety and efficacy of the investigational drug.
- Supports the development of clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).
- Maintains knowledge of the therapeutic area, disease state, and potential drug effects.
- Assesses clinical data to help identify and analyze safety concerns and adverse events Stays current with relevant medical literature and clinical trial methodologies.
- Conducts literature reviews as needed for focused scientific questions or documentation.
- Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to ensure data integrity during the clinical development process.
Requirements
- Advanced degree in life sciences, such as a PhD, PharmD or related field
- Understanding of clinical trial methodologies and regulatory requirements
- Experience in clinical study design, data analysis, data review and interpretation
- Good written and verbal communication skills
- Ability to work effectively in a collaborative, cross-functional environment
- 3 years experience
Benefits
- A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
- Competitive salary and benefits package.
- A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
- Opportunities for professional growth and development.
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