Director, Biostatistics - REMOTE
Company: Penfield Search Partners Ltd
Location: Los Angeles
Posted on: May 16, 2022
|
|
Job Description:
Our client is a thriving CRO whose clients range from large
pharma to small biotech. They are currently recruiting for a
Director of Biostatistics to provide statistical consulting to
clients in their drug development programs with a focus on
comprehensive data analysis strategies of clinical development,
protocol/study design, regulatory submission strategies, regulatory
communication, mentoring of other statisticians in generating
analyses for clinical studies and regulatory submissions, and
assist with business proposals. This position assumes a supervision
responsibility on job training for statistical personnel and
inter-functional management, as well as staff performance review
and budget planning.
Provide statistical consulting to clinical study design and
clinical development program
Review and provide consultation to protocol preparation
Develop analysis plans and strategies for regulatory
submissions
Lead regulatory submission strategy planning for statistics
function
Write statistical reports to interpret analysis results for
regulatory submissions, if needed
Review clinical study reports and other regulatory submission
documents
Participate in integrated analysis strategy discussions with
clients for regulatory submissions
Work with medical writers to assist with ISS/ISE reports
preparation
Participate in regulatory communication
Lead statistical methodology research and stay current on
statistical methodology and drug development
Identify and provide solutions to statistical issues
Mentor other statisticians in their support of client projects to
ensure timely and high quality delivery of analysis package
Ensure that statistical personnel follow the standard operating
procedures
Determine and maintain staff training curriculums
Identify department deficiencies/needs and propose new and/or
revision of standard operating procedures
Assist with preparation of business proposals
Conduct performance evaluation on staff and participate in merit
and budget discussions
Desired for the role:
8-10 years of relevant experience in a health sciences research
institute or the pharmaceutical/biotech industry
Direct participation in design, planning, conduct, analyses, and
reporting of clinical trials
Direct participation in regulatory submission activities
Deep understanding statistical concepts and methodology related to
clinical trials and drug development
Comprehensive knowledge on regulatory guidelines
Excellent organizational and project management skills
Excellent interpersonal and communication skills
Keywords: Penfield Search Partners Ltd, Los Angeles , Director, Biostatistics - REMOTE, Executive , Los Angeles, California
Click
here to apply!
|