Sr. Manager, Biostatistics Contractor

Sr. Manager, Biostatistics Contractor

JOB DESCRIPTION

The Senior Manager, Biostatistics acts as statistical study lead; provides technical input and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results; performs statistical analyses; provides timely support to the project teams on all statistical matters

Responsibilities

·       Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from statistics perspective.

·       Contribute to study level tasks from statistics perspective, including study design and sample size determination, protocol statistics section, SAP and DMC charter; Review study randomization files; Develop TFL shell and specification; Review CRFs and other study documentations; Active participation in study related meetings

·       Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting

·       Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results

·       Contribute to developing standards and research in advanced statistical methodologies

·       Review regulatory documents or scientific publications

Requirements

·       PhD in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry

·       Experienced in NDA / BLA / MAA activities as a contributor from statistics perspective and direct involvement in regulatory interaction is preferred

·       Experienced as or is capable to act as study lead statistician and contribute to strategy discussion in cross functional settings 

·       Experienced in study level work including authoring SAP and TFL specification

·       Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance

·       Solid understanding of mathematical and statistical principles

·       Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline

·       Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies