Statistical Project Leader
- Drive statistical strategy for Medical Affairs studies, including Phase IV trials, observational studies, and statistical expertise on RWE projects
- Lead statistical contribution to Integrated Evidence Generation plans, ensuring scientific rigor, regulatory compliance, and stakeholder relevance
- Independently manage statistical aspects with minimal oversight while engaging leadership on strategic decisions
- Drive innovation by rethinking traditional workflows and implementing cutting-edge statistical methodologies to accelerate evidence generation
- Oversee project planning, timelines, and resources across multiple studies
- Manage relationships with external partners (CROs, academic collaborators, DMCs)
- Partner with Medical Affairs, Clinical Development biostatistics, Pharmacovigilance, Regulatory, HEOR, and other functions to align statistical approaches with business objectives
- Represent Statistics in regulatory interactions and scientific forums
- Proactively identify opportunities to streamline processes and leverage AI-powered solutions to enhance project efficiency
- Mentor junior statisticians and statistical programmers
- Foster a culture of innovation, scientific excellence, and continuous improvement
- Champion quality standards while promoting operational efficiency
- Lead by example in adopting AI and automation tools to transform statistical workflows and unlock significant productivity gains
- 7+ years (MS) or 5+ years (PhD) of pharmaceutical industry experiences in clinical trials and/or medical affairs.
- Proven track record of delivering results in complex, fast-paced environments
- Broad knowledge and good understanding of advanced statistical concepts and techniques, including their application in observational and RWE studies (e.g. Causal inference methods, target trial emulation, pragmatic clinical trials)
- Demonstrated strong project/study management, interpersonal and communication skills.
- Good knowledge of pharmaceutical clinical development and medical affairs
- Extensive ability to apply advanced statistical analyses using SAS and/or R languages.
- Results-driven mindset with ability to rethink and optimize workflows, challenging the status quo to drive continuous improvement
- Knowledge or experience with Artificial intelligence or Generative AI is a plus
- Enthusiasm for levering AI and Generative AI technologies to reform statistical practices
Education : MS or PhD degree in Statistics or relevant fields Languages : Highly effective communication in English, both oral and written. Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Develop a career of being an influential statistician, continually learn about statistical innovation and apply your learnings on your projects
- Gain international clinical trial experiences and communicate with Health Authorities worldwide
#LI-Onsite All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Recommended Jobs
Experienced Paralegal - Litigation / Professional Liability / Defense - Mt. Laurel, NJ
The law offices of Marshall Dennehey, a large civil defense litigation firm, is seeking a full-time Paralegal for its Mount Laurel, NJ office with Litigation / Professional Liability. Litigation incl…
Ultrasound Tech
Overview Join our team as a variable shift, PRN, Maternal Fetal Medicine Ultrasound Technician in Montclair, NJ. Why Join Us? Thrive in a People-First Environment and Make Healthcare B…
Principal Product Manager 764
At Protegrity, we lead innovation by using AI and quantum-resistant cryptography to transform data protection across cloud-native, hybrid, on-premises, and open source environments. We leverage advanc…
Restaurant Supervisor- Michael Patrick's
Overview: Restaurant Supervisor It is the responsibility of the Restaurant Supervisor to manage operation in an efficient and professional manner to ensure quality service to guests. Responsibil…
Sr Maintenance Technician
The Senior Facilities Maintenance Technician is responsible for maintaining and repairing the physical infrastructure of the organization. This role involves ensuring that facilities are safe, functi…
Business Operations Analyst- Loan Sales
Job Description Embark on a rewarding and challenging career as an Operations Analyst with our dynamic team where you'll have the opportunity to make a significant impact by supporting process imp…
Tax Manager (Partnerships) - Richmond, VA (Work from Home Possible)
Our client is a 150 staff CPA firm in the city of Richmond, VA. They have a heavy focus on working with high net worth individuals and their privately held companies and pride themselves on offering …
Business Development Manager- Eastern Region
Business Development Manager – Eastern Region Drive growth. Build global trade partnerships. Shape the future of our Transatlantic & Transpacific business. About the Role We’re seeking an …
Lab Director - Anatomic Pathology
We are seeking a dedicated and experienced Director of Laboratory Operations to oversee operations for our full service Anatomic Pathology Laboratories located in Raritan, NJ as well as satellite…