What are the responsibilities and job description for the Associate Director/Director Statistical Programming position at GQR?
This role can either be perm, contract-to-perm or contract
Position Overview :
Responsible for overseeing statistical programming activities for multiple clinical studies and performing quality review of CRO / Vendor SAS programs and deliverables. The individual will also perform programming analyses to generate ad-hoc requests for publications, presentations, and responses to regulatory agencies' requests.
Reporting Relationship : Reports to the VP, Biometrics.
About the Company :
A clinical-stage biopharmaceutical company focused on developing innovative therapeutics for rare diseases affecting bone health and blood vessel function.
Desired Skills & Experience :
- 8 years of statistical programming experience in the CRO or pharmaceutical industry.
- 7 years of people and / or project management experience in the CRO or pharmaceutical industry.
- BS / MS degree in life sciences, computer science, statistics, mathematics, or a related field.
- Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
- Familiarity with validation tools, such as Pinnacle 21.
- Strong understanding of data collection and database concepts, including clinical trial data collection processes.
- Experience with outsourcing programming activities and overseeing CROs and contractors.
- Experience in regulatory submissions.
- In-depth knowledge of pharmaceutical clinical development, including statistical concepts, techniques, and clinical trial principles.
- Familiarity with industry standards such as CDISC data standards, controlled terminology, FDA guidance (e.g., 21 CFR Part 11), and ICH requirements.
- Ability to develop and implement strategies for efficiency in a fast-paced environment.
- Strong project management skills.
- Skilled in issue resolution, process improvement, and execution.
- Excellent verbal and written communication skills in a global setting.
- Proven ability to collaborate with cross-functional teams, including Data Management, Biostatistics, Clinical Operations, Pharmacovigilance, and Medical Affairs, to drive initiatives and improvements.
