Summary of Position:
The successful candidate will be a technically strong SAS programmer with biopharmaceutical experience in oncology who can collaborate with members of cross-functional teams to support Data Management and Biostatistics functions, individual protocols and integrated databases planning for electronic submissions, oversight and guidance for CRO provider’s SAS programming services, and in-house ad hoc analyses as needed. Aravive is a fast-paced, small organization and the ability to be productive and focused in an intense and collaborative work environment is critical.
Job Title: Director, Statistical Programming
Reports to: Executive Director, Data Sciences
Employment Type: Full-Time
Location: US East Coast (NC preferred)
FLSA Status: Exempt
Date: Fall, 2020
Key Essential Functions:
- Guides setup and oversight of CDISC compliant database structures for individual clinical trials in collaboration with Data Sciences leadership and our CRF data services provider.
- Guides setup and oversight of CDISC compliant database structures for product-specific integrated databases suitable for e-submissions, in collaboration with Data Sciences leadership and our CRF data services provider.
- Assists with identifying automated edit checks within EDC systems used for clinical trials data accrual.
- Manages Aravive’s hosted SAS environment (software and data)
- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
Required Skills & Abilities:
- Must have a thorough working knowledge of SAS software as used in oncology clinical trials
- Knowledge of JMP Clinical preferred and expertise in providing publication-ready graphics from SAS and JMP Clinical
- Fluent with writing and reviewing database and analysis specifications
- Fluent with CDISC SDTM and ADaM guidances (SEND and NCI familiarity also helpful)
- Ability to work independently with minimal supervision, manage a variety of tasks with competing priorities, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess strong project management skills
- Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
- Ability to communicate technical information in a clear and concise manner
- Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
- Excellent organization skills with acute attention to detail
- Strong desktop computer skills for MS Office products
- Bachelor’s degree +8 years, Master’s Degree + 5 years, Doctoral Degree + 2 years of relevant SAS programming experience in the pharmaceutical industry, especially in oncology; advanced certifications in SAS a plus. Title will be commensurate with experience.
- Proven successful experience with SAS programming for data management and statistical analysis functions.
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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