We're looking for a Director of Statistical Programming, working in the Pharmaceuticals & Medical Products industry in Woodcliff Lake, New Jersey, United States.
Manages collaborations with external alliances for all programming related activities.
Ensures successful and effective coordination and communications
Manages, reviews and / or executes statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies
Leads global submission activities including cross-company projects.
Acts as a programming functional and technical expertise to support submission strategy planning, regulatory communication
We're offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Minimum of a Master's degree in Biostatistics, Statistics, Computer Science, or related discipline; Bachelor degree with extensive experience might also be considered.
At least 12 years of relevant experience in statistical programming in the pharmaceutical industry/CRO environment with people and project management experience.
Highly experienced in clinical development statistical programming methods and processes in industry setting required.
Regulatory submission experiences in the area of Oncology indications.
Have lead programming activities involving CDISC SDTM, Adam, eSub.
Experience with CRO oversight.
Strong organizational skills with the ability to effectively manage multiple studies/projects.
Excellent technical writing and verbal communication skills.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.