We have a current opportunity for a AD Biostatistics on a permanent basis. The site location is in New Jersey. This position can be remote or hybrid on site. We're seeking talented Biostatisticians that have pharma industry experience in Oncology early/late phase. For further information about this position please apply.
Job Title: Associate Director, Biostatistics
Location: New Jersey
Company Overview: We are a mid-sized oncology pharmaceutical company dedicated to developing innovative cancer therapies. Our mission is to improve patient outcomes and quality of life through cutting-edge research and development.
Position Overview: The Associate Director of Biostatistics will provide strategic and statistical leadership for our late stage oncology clinical development programs. This role involves designing and analyzing clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to support the development of new cancer treatments.
Key Responsibilities:
- Provide statistical leadership and support for oncology clinical trials, including study design, statistical analysis plans, and data interpretation.
- Collaborate with clinical teams to develop case report forms and ensure accurate data collection.
- Conduct statistical analyses and provide input for clinical study reports, scientific presentations, and manuscripts.
- Lead discussions with regulatory authorities and serve as a statistical responder in FDA advisory committee meetings.
- Develop and implement statistical standard operating procedures (SOPs) and contribute to process improvements.
- Mentor and develop junior biostatisticians and other team members.
- Stay current with advancements in biostatistics and oncology research to ensure the application of best practices.
Qualifications:
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
- Minimum of 8 years of experience in biostatistics, with at least 5 years in the pharmaceutical or biotechnology industry.
- Strong knowledge of statistical methods and their application in clinical trials.
- Experience with regulatory submissions and interactions with health authorities.
- Proficiency in statistical software (e.g., SAS, R).
- Excellent communication and leadership skills.
- Ability to work collaboratively in a cross-functional team environment.
Preferred Qualifications:
- Experience in oncology clinical trials.
- Familiarity with FDA and EMA guidelines for drug development.
- Demonstrated ability to lead and manage multiple projects simultaneously.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- 401(k) with company match.
- Professional development opportunities.
- Flexible work arrangements.
