Description
The Associate Director/sr Manager, Biostatistics, acts as fully independent Statistical lead responsible for one or multiple drug projects. This person interacts with regulatory authorities and key opinion leaders and supervises other Statisticians providing support to the projects.Major Duties/Responsibilities
Provides Statistical advice to clinical teams including design of studies and analyses requiring advanced statistical methodologies.
- Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, Statistical methods, data structures and presentation of results
- Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses
- Develops Statistical Analysis plan and other supporting documents
- Ensures Statistical analyses performed in accordance with the protocol, Statistical analysis plan, good Statistical practice, and available regulatory guidelines.
- Provides (executive) topline reports of study results
Provides adequate vendor oversight of the study deliverables created. for ex - ADAM/SDTM datasets, TFLs etc.
- Perform vendor qualification / audits in collaboration with functional management
- Investigates new Statistical methodology and software and provides feedback to department
- Resource planning and hiring
- Mentors junior level Statisticians and CRO staff
- Develops and maintains work instructions, guidelines and budget for Biostatistics
Skills & Abilities
- Excellent organizational, interpersonal and leadership skills
- Excellent communication skills - Able to clearly communicate Statistical issues to diverse audience
- Keen eye for detail
- Dedication to quality and reliability
- Good negotiation skills
To find out more about Real please visit www.realstaffing.com