Details: A Sr. Clinical Statistician job in Whippany, New Jersey is currently available through Belcan. To be considered for this role you will be well experienced in providing statistical expertise to cross-functional teams and ensuring the use of appropriate and efficient statistical analysis methods during the development, submission and/or life-cycle management of products according to applicable global and regional standards, procedures and regulatory guidelines for oncology development studies and projects.
Sr. Clinical Statistician Duties and Responsibilities:
• Collaborate with representatives from other functions to plan, execute, analyze and report relevant studies for oncology clinical development studies under the guidance of an experienced statistician.
• Contribute to the preparation of the study protocol to develop the statistical analysis plan for the study as appropriate (including contributions to other deliverable s such as TLF/ADS specifications), and be involved in reporting results in the clinical study report, ensuring overall consistency within and between projects.
• Facilitate the overall organization and coordination of statistical activities for specific studies and small projects and lead or participate in virtual cross-functional sub-teams within Medical Writing and Statistics Oncology.
• Assume responsibility for the production and accuracy of the statistical deliverable s and interpretation of the results and develop and implement standard processes for the analysis of routine (parts of) oncology studies and oversee and ensure accurate and timely delivery of statistical work outsourced to external providers.
• Oversee and ensure accurate and timely delivery of statistical work outsourced to external providers.
Sr. Clinical Statistician Requirements and Preferences:
• PhD or MSc in Biostatistics, Statistics or Mathematics, or related field.
• At least five years’ experience as a statistician with significant time spend in pharma, biotech or similar sector.
• Good knowledge of statistical programming languages (including SAS and R).
• Ability to work independently as well as collaboratively, as required with strong communication skills and fluent English skills.
• Substantial hands-on experience supporting phase I-III clinical studies in the Oncology therapeutic area is preferred.