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