Lead Biostatistical Innovator
As a seasoned expert in biostatistics, you will spearhead Phase II-III clinical studies across your region.
You are excited and enthusiastic, motivate your teams to excel and collaborate seamlessly with clients.
Sponsor-dedicated : You'll be at the forefront of our client's innovation, driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
Our team provides statistical and development support and influence for associated trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors.
- Providing statistical input into study protocols, Case Report Forms, and data management plans.
- Incorporating Estimand framework while authoring study documents.
- Creating specifications and performing analyses such as time-to-event and longitudinal analysis.
- Reviewing and contributing to study reports and clinical and statistical sections of regulatory submission dossiers, leading electronic submissions of clinical data to regulatory authorities, and participating in meetings with regulatory authorities.
- Managing biostatisticians and statistical programmers, delivering statistical strategy, deliverables and processes.
- Generating innovative statistical methodology approaches, identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project.
Key Qualifications
PhD in statistics or master's degree in statistics or related subject required along with clinical trial experience.Relevant experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma / biotech industry preferred.Understanding of the application of biostatistics to medical / clinical trials data.Excellent verbal and written communications skills.Ability to organize multiple work assignments and establish priorities.Working SAS & CDISC knowledge required. Experience in R / R Shiny is preferred.We Offer
A dynamic work environment that fosters growth and collaboration.
The opportunity to contribute to groundbreaking research and development.
Professional development opportunities to enhance your skills and expertise.
Flexibility and autonomy to manage your workload and prioritize tasks effectively.