Director of Biostatistics

Director Of Biostatistics

Our client is an exciting clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. The Company has developed a proprietary technology designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat.

The Company believes the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using this proprietary technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of the platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond initial targets and also to be applicable in oncology, infectious disease and other critical disease areas.

The current target application is currently in a Phase 1b/2 trial. Potential pipeline indications include candidates for other indications, each designed to improve on the activity and tolerability of currently approved drugs.

Our client is looking for people who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in Canada.

Scope

The Director of Biostatistics provides strategic and operational leadership for biostatistical activities within and across clinical development programs. This role is responsible for ensuring the integrity, quality and rigor of statistical analyses and methodologies applied to clinical studies. They will serve as the primary statistical representative in cross-functional teams and lead biometrics related activities for regulatory submissions (IND, NDA/BLA, MAA). This role may supervise junior statisticians or function as a senior individual contributor.

Key Responsibilities And Duties:

• Leads and oversees biostatistical strategy for one or more clinical development programs.
• Serves as a key contributor to study design and protocol development.
• Develops statistical analysis plans (SAPs) and table, listing, and figure (TLFs) shells.
• Ensures that clinical trial designs and proposed analysis methods are robust and follow regulatory guidelines (FDA, EMA, etc.)
• Oversees the production of TLFs for interim and final analyses and ensures that it is of high quality and delivered on time.
• Provides hands-on oversight of CROs and external statistical reporting groups to ensure quality standards and timelines are met for statistics related deliverables.
• Manages statistical vendors for independent data monitoring committees
• May supervise junior biostatisticians

Education, Qualifications And Work Experience:

• Master's degree or PhD in biostatistics or statistics
• 15+ years of biotech/pharma experience as a biostatistician
• Demonstrated experience supporting pivotal and registrational clinical trials
• Strong CRO and vendor oversight experience
• Track record of delivering high quality statistical related deliverables
• NDA/BLA experience

Additional Attributes:

• Excellent knowledge of SAS
• Experience with sample size calculation software such as nQuery, EAST, etc.
• Knowledge of R a plus

Salary Range: $225,000 to $260,000 depending on education and relevant work experience