Summary of Position:
We are seeking a Sr. Statistical Programmer with extensive SAS programming expertise gained within an oncology clinical drug development program. This role offers the potential for career growth and additional responsibilities as Aravive expands its clinical development programs. The Sr. Statistical Programmer will ensure programming conducted by a contract research organization (CRO) is consistent with CDISC standards and that analyses, tables, figures and listings align with study protocols and statistical analysis plans. The Sr. Statistical Programmer will collaborate with Aravive colleagues and develop internal data standards and processes, and ad hoc analyses and reports. The Sr. Statistical Programmer will also work with data managers to ensure the quality of the data and audit trails.
Job Title: Sr. Statistical Programmer – Oncology
Employment Type: Full-Time
FLSA Status: Exempt
Key Essential Functions:
- Work cooperatively with study team members including but not limited to biostatisticians, CRO statistical programmers, data managers, and clinicians.
- Oversee the CRO statistical programmers
- Oversee the development of specifications for converting raw data to SDTM and ADaM datasets, and ensuring the datasets are programmed according to approved specifications.
- Review clinical study protocols with regard to statistical programming responsibilities
- Review and provide input to Statistical Analysis Plans and Statistical Programming Plans
- Review and provide input to Case Report Forms
- Ensure tables, figures and listings are programmed according to approved specifications.
- Review accuracy of results produced for clinical study reports
- Develop and maintain ADaM and STDM specifications for Aravive clinical studies
- Inform management of the status of statistical programming deliverables and issues
- Produce ad hoc data analyses and reports
- Contribute to standards and process improvements
Required Skills & Abilities:
- Expertise in CDISC standards and industry best practices for oncology studies
- Advanced SAS programming skills; competent with macro programming
- Excellent understanding of relational databases such as EDC systems
- Ability to create CDISC compliant datasets from raw data
- Understanding of requirements for regulatory submissions
- Advanced knowledge of inferential statistics is preferred.
- Working knowledge of regulatory agency requirements (e.g., FDA, EMA) and guidance documents
- Experience handling external data such as lab data, PK data, imaging data, etc.
- Working knowledge of MedDRA
- Excellent oral and written communication skills, ability to work productively in a fast-paced and collaborative team environment
- Ability to work independently in virtual R&D organization with demonstrated ability to independently design and execute experimental plan.
- Excellent organization skills with acute attention to detail
- At least five years of oncology industry experience and expertise as a SAS statistical programmer for Phase 1, 2 and 3 studies. Lead programmer experience is expected
- Demonstration of leadership skills and abilities
- Experience guiding the development of clinical trial databases
- Experience leading regulatory submissions
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.
Please send resumes and cover letters to firstname.lastname@example.org