Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022.
Primary Responsibilities
Primary responsibility of this position includes, but is not limited to the following: • Managing the Statistics, Statistical Programming and Data Management functions • Supervising direct reports in each function • Serving as the primary statistician for the clinical studies • Providing statistical input to protocols, writing statistical analysis plans, and analyzing data. • Creating, implementing, and maintaining programming development plans that account for timelines, resources and quality deliverables • Creating and reviewing programming plans and specifications for datasets and TLFs. • Programming, testing and documenting SAS programs • Working with clinicians on the best ways to analyze data as well as ensuring the statistical methods are appropriate • Providing statistical and general support • Managing the statistical programming support of FDA/EMA regulatory submissions and ensuring they follow CDISC standards • Implementing the CDISC standard at the CRF and database build-up stage • Reviewing mock tables, programming plans and specifications for datasets and TLFs • Collaborating with others to ensure continuous improvement and milestones are met • Overseeing the vendors contracted to conduct activities on Iterum’s behalf (such as programming, data handling, data transfer specifications, data cleaning, etc.) • Preparing appropriate data sets to support Regulatory requirements and requests • Developing best practices for data handling • Ensuring the timeliness and integrity of data transfers from all vendors • Development of CRF/eCRF completion guidelines • Ensuring efficient eCRFs and database designs are developed and managed • Exploring new methodologies to improve productivity and efficiencies
Education and Training
A minimum of a master’s degree in Statistics is required • A minimum of 15 years hands on career experience in statistics, statistical programming and data management in the pharmaceutical or biotechnology industry • Strong leadership and communication skills • Experience in leading teams supporting regulatory submissions • Capable of working in a complex and diverse environment • Experience in development and implementation of statistical programming standards and procedures is required. Experience using industry standards such as CDASH, SDTM, and ADaM.