Penfield Search Partners
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