Associate Director/Director Statistical Programming
- Statistical Programming| FDA Submissions | Phase I-IV Clinical Trials
- Greater Boston Area
- $175,000 - $220,000 +complete benefits package
A growing biotech company that is dedicated to transforming scientific discoveries into life changing treatments is looking to push the boundaries of biotechnology, focusing on research and development to improve health outcomes globally. This growing company offers a culture of innovation, collaboration, and excellence, and are making significant strides in personalized medicines, genomics, and bioinformatics. Due to a robust R&D pipeline, there are a variety of research and therapeutic areas of interest.
The AD/Director of Stat Programming will have responsibilities that include:
- Leadership & Management: Lead and mentor a team of statistical programmers, fostering a collaborative and innovative work environment.
- Strategic Planning: Develop and implement strategies for statistical programming to support clinical development and regulatory submissions.
- Data Analysis & Reporting: Oversee the analysis of clinical trial data, ensuring accuracy, consistency, and compliance with regulatory requirements.
- Collaboration: Work closely with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs, to achieve project milestones.
- Innovation: Stay abreast of industry trends and technological advancements to continuously improve our statistical programming capabilities.
The ideal candidate will have the following skill set:
- 10+ years in stat programming in life sciences preferred.
- Experience with managing complex statistical data and with analytic statistical software
- Experience with FDA regulatory submissions
- Familiarity with CDISC relating to FDA guidelines
- 7+ years of experience in managing stat programming teams
- Phase I-IV clinical trial experience
- Excellent verbal and written skills
- Advanced degree strongly preferred
