We have a current opportunity for a Director Biostatistics RWE on a permanent basis. The site location is based in New Jersey, but position can be remote. For further information about this position please apply.
Job Title: Director of Biostatistics, Real-World Evidence (RWE)
Position Summary: The Director of Biostatistics, RWE, will lead the statistical strategy and analysis for real-world evidence studies. This role involves collaborating with cross-functional teams to design, analyze, and interpret data from observational studies, registries, and other real-world data sources. The ideal candidate will have a strong background in biostatistics/RWE, experience in the pharmaceutical industry, and a passion for improving patient outcomes through data-driven insights.
Key Responsibilities:
- Lead the design and analysis of real-world evidence studies, including observational studies, registries, and other real-world data sources. (multple studies/ serve as project level statistician)
- Develop and implement statistical analysis plans (SAPs) for RWE projects.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and health economics, to ensure the integration of RWE into the overall product development plan.
- CRO/Vendor Selection and oversight
- Leads the planning and analysis of integrated efficacy and safety data
- Ensure the quality and integrity of statistical analyses and data interpretation.
- Author and review statistical sections of study protocols, reports, and regulatory submissions.
- Stay current with advancements in biostatistics and real-world evidence methodologies.
- Mentor and develop junior biostatisticians and other team members.
Qualifications:
- Master's degree in statistics, biostatistics, or a related field; PhD preferred
- 10+ years of experience in the pharmaceutical industry with a master's degree, or 7+ years with a PhD
- Strong knowledge of real-world evidence methodologies and observational study design
- Proficiency in statistical software such as SAS, R
- Excellent communication and interpersonal skills.
- Ability to work effectively in a collaborative, cross-functional team environment.
- Strong problem-solving skills and attention to detail.
Preferred Skills:
- Experience with regulatory submissions and interactions with health authorities
- Knowledge of health economics and outcomes research (HEOR) principles
- Experience in oncology, cardiovascular
.
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional development and career advancement.
- Collaborative and innovative work environment.
