Summary of Position:
The successful candidate will be responsible for overseeing all statistical activities associated with Aravive’s clinical studies. The successful candidate will work collaboratively with in-house clinical, non-clinical and data management groups, as well as their external vendor counterparts and statistical programmers, to plan and execute analyses of all types of clinical studies, including clinical pharmacology.
Job Title: Senior Director Biostatistician
Employment Type: Full-Time
Location: RTP, NC
FLSA Status: Exempt
Key Essential Functions:
- Provision of timely and scientifically sound statistical expertise to clinical, clinical pharmacology and non-clinical development projects.
- Interact with members of project teams, clinical scientists, clinical pharmacologist, statistical programmer and data management personnel to establish project timelines, data validation checks and perform statistical analyses.
- Responsibility for providing statistical expertise in clinical study design and analysis.
- Collaborate in the preparation and review of protocols, CRF design and clinical study reports.
- Develop statistical analysis plans, perform exploratory data analysis as necessary and provide data interpretation.
- Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results.
- Collaborate with Data Management and Clinical Operations staff to implement guidelines and standards to CROs to ensure quality of deliverables.
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
Required Skills & Abilities:
- Excellent oral and written communication skills
- Excellent organization skills with acute attention to detail
- Ability to work and multi-task in a fast-paced environment
- Strong computer skills, including SAS and dashboard systems
- Current experience in biotech industry
- PhD or Masters in biostatistics.
- Minimum of 7 years pharmaceutical industry experience with clinical trials, particularly in study design and analysis.
- Experience with regulatory submissions is necessary.
- Experience with CRO management or oversight.
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer and fibrosis. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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