Job Description Summary:
The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials. This includes, but is not limited to: identifying optimal study designs, defining data analysis strategies, implementing statistical analysis plans, interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders. The incumbent may interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials.
The incumbent works cross-functionally with internal departments and external resources on Biostatistics related issues.
The Director, Biostatistics ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:
- Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses.
- Develops solutions to statistical and data analysis issues for clinical and regulatory. Communicates solutions cross-functionally.
- Participates in vendor evaluation, selection, and management.
- Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
- Reviews Case Report Forms (CRF's), annotations, and edit checks to ensure capturing of all required data in a way that supports a high quality database for the planned analyses.
- Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions.
- Authors and reviews statistical and outcome sections of study reports and submissions.
- Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
- Advanced degree in Statistics or a related statistical discipline and a minimum of 8 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies.
- Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry.
- Prior BLA, NDA and/or MAA experience is highly desirable
- Hands-on statistical programming skills using SAS and/or R.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
- Excellent understanding of regulatory requirements and guidance documents
* Travel requirements: 5- 15%