Job Description :
Job role- Senior Biostatistician
Location: South San Francisco, CA
Duration- Fulltime
Job Description:
The Senior Biostatistician provides statistical leadership for Actelion US medical affair initiatives. This individual is responsible for all biostatistical 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 studies
Participates 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 deliverables.
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 deliverables 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.
Required
Master''s or Ph.D. in mathematics, statistics, biostatistics, or related disciplines with 10 years relevant experience.
Preferred
Sound 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.