Associate Director Biostatistics

This position will report to the Senior Director of Biostatistics and Data Management. This east bay client is looking for a key member of the development team for assigned studies. The successful candidate will understand the implications and logistics of the study protocol requirements and will ensure that appropriate processes and procedures are put in place for timely, high quality deliverables.

Some responsibility includes preparation of the statistical analysis plan and the execution of all the supporting activities for its successful implementation, including validation of underlying databases.

This pharmaceutical development company is focused on anti-infective therapies for the treatment of life-threatening infections.

Responsibilities:

- Interact with clinical research personnel, data management and medical writers in planning, design, conducting, evaluation, interpretation and presentation of study results and reports; including but not limited to protocol and Case Report Form (CRF) review, writing statistical sections of protocol, database design, edit check specifications, and external data specifications
- Proactively identifies issues and proposes solutions in support of activities that are specific to anti-infectives, such as patient evaluability and pathogen determinations
- Assist in the selection of appropriate statistical methods for design and analysis of studies and projects; advise medical team members on statistical results
- Contribute to preparation of responses on statistical issues raised by regulatory agencies
- Assist with the preparation of relevant components of NDA and other documents for regulatory submission
- Oversee CRO and contractors on all ongoing activities related to statistical analysis of clinical trial data; promptly alert data management of any issues noted which impact statistical deliverables
- Support the review of CRFs and write key project documents, including Statistical Analysis Plans
- exhibit understanding of cross-functional issues across all project phases and contribute so effective resolution of issues
- Takes a leadership role in ensuring that statistics deliverables are generated on time and with quality for assign protocols and projects
- Provide statistical support to new drug in-licensing, development, submission, approval, and marketing activities

Requirements:

Education: Ph.D. (preferred) in Statistics or Biostatistics with minimum 6 years of pharmaceutical statistics experience with specific experience in late stage drug development; Master's in Statistics or Biostatistics accepted with 9 years of pharmaceutical statistics experience experience.

- Ability to build collaborative internal and external relationships
- Excellent oral and written communication skills
- Work independently with a sense of urgency and commitment to project timelines in a fast-paced, high change environment
- Takes initiative to develop consensus and is able to positively manage change
- Assumes responsibility and accountability for results; encourages team members to meet and exceed shared goals; ability to train others and willingness to share knowledgeTo find out more about Real Staffing please visit www.realstaffing.com