Role:Senior Bio statistician
Location: South San Francisco, CA
Job Summary :
The Senior Bio statistician provides statistical leadership for medical affair initiatives.
This individual is responsible for all bio statistical aspects of the projects and/or trials and participates in the development and implementation of U.S. Medical Affairs strategies, design, analysis and publication of results of Medical Affairs studies.
Job Responsibilities :
- Primary responsibilities include the following. Other duties may be assigned.
- Coordinates and provides statistical representation for all Medical Affairs studiesParticipates protocol and CRF development with other clinical team/clinical trial team including study design, analysis plan, and reporting.
- Supports analysis of Medical Affairs studies and associated publications.
- Ensures statistical design is compatible with the trial objectives.
- Develops statistical analysis plan.Provides quality assurance on data and all statistical deliverable.
- Performs statistical analysis.Writes or supports the writing of the statistical section/module of study reports and publications.
- Serves critically reviews for abstracts, posters and publications.
- Verifies adherence to statistical standards and SOPs within the project.
- Supports and leads continuous development and improvement of statistics and programming processes.
- Provides statistical oversight for projects utilizing contract research organizations (CROs).
- Support for development of statistical standards and SOPs.
- Provides resource plans and timelines for deliverable for assigned projects.
- Serves as statistical resource to other functions, provides statistical education.
- Collaborates and communicates effectively with Global Medical, Life Cycle Team and other relevant teams in relation to assigned responsibilities and projects.
Candidate Qualifications & Requirements :
- This job requires a combination of analytical, organizational and interpersonal skills.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- RequiredMaster's or Ph.D. in mathematics, statistics, bio statistics, or related disciplines with 10 years relevant experience.
- PreferredSound knowledge of applied statistics, including survival analysis and epidemiological methods.
- Experience working on post-marketing studies.
- Experience in supporting congress presentations and publishing in peer-reviewed clinical journals.
- Experience in coordinating statistical support for a multifaceted project, including managing outsourced statistical services.
- Professional demeanor with proficient written and oral communication skills; ability to engage effectively throughout all levels of the organization and externally with key opinion leaders.
- Strong statistical analysis skills in SAS and R.Able to work effectively in a multi-disciplinary team.
- Knowledge of international clinical research regulations and requirements.
- Ability to work efficiently in an international team environment.
- Excellent interpersonal and communication and management/coaching skills.Must be able to work according to timelines and achieve project deadlines.