Reporting to the Vice President of Clinical Development, the successful candidate is a highly motivated Biostatistician with proven abilities and expertise in drug development, who will drive activities in support of timelines and budgets related to product development for all Homology programs.
Essential Functions and Duties:
- Lead the statistical strategy across Homology programs
- Direct/oversee the statistical and programming support activities for Homology clinical studies
- Work with head of clinical development to ensure optimal clinical trial designs and protocol development
- Ensure all study- and project-level statistical and programming activities are conducted using high quality standards
- Ensure consistency of statistical and programming approaches utilized across programs
- Accountable for the timely production and accuracy of all statistical analyses, programmed outputs and integrated scientific reports for clinical trial results, exploratory analyses, publication activities, scientific presentations and promotional materials
- Participate in vendor selection, and provide oversight function on biostatistics activities and associated deliverables for outsourced clinical studies
- Responsible for the creation of statistical sections of protocols and statistical analysis plans
- Contribute to the design and compliance of data capture methods (CRFs, other), and participate in development of clinical study reports.
- Provide statistical expertise and support to both preclinical and developmental research activities
- Oversee the preparation for data monitoring and data review meetings.
- Develop statistical processes and reporting standards, including but not limited to 1) review of tables / listings / figures, 2) confirm CDISC / CDASH labeling of datasets has occurred, etc.
- Participate as content expert on cross-functional development teams
- Contribute to all relevant submissions, including briefing documents that will be sent to regulatory authorities and participate in regulatory agency meetings, as needed
Skills and Experience:
The ideal candidate will have a PhD in (bio)statistics with strong knowledge of theoretical statistical methods applied to clinical trial design. A minimum of 5 years of experience in the biopharmaceutical industry or a contract research organization including regulatory submissions are required. Candidate must also have experience in orphan drug development. Experience in gene therapy trial design is a plus.
In addition, the candidate will have:
- Strong programming skills with common statistical software packages such as SAS®, S-Plus, PASS, nQuery advisor, EAST
- Thorough knowledge of industry standards, as well as ICH, EMEA and FDA guidelines and regulations on clinical trials, statistics, and data management, with a solid understanding on how to apply best practices for analysis and reporting activities, study designs and statistical methods
- Demonstrated ability to work independently and strong leadership skills
- Strong problem solving skills, as well as excellent verbal and written communication skills
- Superior presentation skills, and the proven ability to work in a team setting
- Must be highly motivated, resourceful and willing to work hands-on on several projects
- Must be comfortable with change and able to adapt quickly
Interested candidates should forward a cover letter and resume/CV to firstname.lastname@example.org.