Job Posting Title: Associate Director, Biostatistics, Clinical Data Sciences
Description: Associate Director, Biostatistics, Clinical Data Sciences
The AD of Biostatistics works directly with the project team and Clinical Data Sciences peers to provide functional input into study design and clinical development, author statistical sections of documents such as protocol, SAP, and CSR, in addition to implementing planned and ad hoc statistical analyses to forward the clinical programs and address requests from various stakeholders.
Role and Responsibilities
Provides advanced input into the statistical sections and overall consistency of the protocol and clinical study report.
Develops and reviews statistical analysis plans. Determines appropriate definitions for clinical endpoints and analysis methods based on the protocol in conjunction with the clinical team.
Responsible for the datasets and outputs for the clinical trial and insures their correctness, quality and consistency with the statistical analysis plan. Performs the preparation, execution, reporting and documentation of high-quality statistical analysis according to the statistical analysis plan.
Work with data management and statistical programming group to develops SDTM and ADaM datasets and dataset specifications required for planned tables listing and figures.
Provide guidance for tables, listings and figures programming specifications as needed.
Works with the data management team to review CRFs to ensure that data collected meets the protocol requirements and helps insure data quality throughout the trial
Responsible for statistical considerations in FDA submissions
Provides support to Data Safety Monitoring Boards by preparing and presenting the appropriate output
Generates sample size calculations appropriate for the primary endpoint based on the protocol
Prepares and reviews statistical methods and results sections for the clinical study report with the medical writers and clinical team
Generates and reviews randomization schedules per protocol and randomization schema
Assists in the development of project timelines, Standard Operating Procedures and guidance documents
Administrates as appropriate the receipt, collation and incorporation of review comments needed for completion of the statistical analysis plan, and result
Communicates competently and independently with the clinical team to coordinate statistical and programming activities of the project.
Advise clinical development, study design and regulatory interactions as appropriate.
The ideal candidate will possess an advanced scientific degree MS in statistics or equivalent or PhD in statistics or equivalent.
At least 7 to 10 years of statistical analysis experience in the pharmaceutical or biotechnology industry preferably in oncology
Proficiency in at least one statistical software, such as R or SAS. Strong working knowledge in SAS (SAS STAT, SAS BASE, SAS MACROS, SAS/ODS and SAS GRAPH)
Strong knowledge of study design and statistical analysis methods in oncology trials is a prerequisite.
Working knowledge of SDTM/ADaM
Knowledge with ICH, Google Cloud Platform, and regulatory guidelines
Experience and Skills
Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time
Ability to work professionally and proactively with diverse team members
Excellent verbal and written communication and the ability to write and edit complex material to ensure accuracy clarity and effectiveness
Ability to think and act independently and interdependently.
Expert understanding of the drug development process
Self-motivated, hardworking, dependable and positive team-oriented personality
Ability to communicate effectively with clinical, statistical programmers, and data management
Current knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of eCTD requirements with respect to structure, format and content
Strong PC Experience and demonstrated proficiency with the MS Office Suite applications, Adobe Acrobat, and electronic document management systems