Director, Biostatistics
- Cambridge, MA
- Permanent
- Full-time
Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.This is life-changing work, and we are all in, are you?Job SummaryThe Director, Biostatistics will play a major role in shaping cohesive biostatistics strategy and direction through effective optimization and integration of all groups within their area of responsibility. The successful candidate is a highly motivated Biostatistician with proven abilities who will drive activities, performed primarily through vendors, in support of project timelines and budgets related to drug product development for all Akebia compounds.Essential Functions & Duties
- Directs/oversees the statistical and programming support for Akebia clinical studies and ensures optimal clinical trial designs and statistical analysis methods.
- Ensure all study and project level statistical and programming activities are conducted using high quality standards and ensure consistency of statistical and programming approaches utilized.
- 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.
- Oversee and participate the creation of statistical sections of protocols and statistical analysis plans, contributes to the design of data capture methods (CRFs, other), and participate in development of clinical study reports.
- Respond to data requests from company team members providing statistical analysis output for ad-hoc and exploratory analyses.
- Statistical support of pre-clinical 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.
- Provide input into all relevant submissions, including briefing documents that will be sent to regulatory authorities and participate in regulatory agency meetings, as needed.
- MS or PhD in (bio)statistics with the ability to apply correct theoretical statistical methods in clinical trial applications.
- 7+years of industry experience is required for PhD candidates
- 10+years of industry experience is required for MS candidates.
- Experience is required in the biopharmaceutical industry or a contract research organization
- Must have experience in regulatory approval submissions.
- 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 able to travel up to 20%, domestically and internationally