Biostatistics Principal Medical Affairs Biostatistician (US)- REMOTE California
Orbis Clinical is seeking a remote-based Principal Medical Affairs Biostatistician for 6 months.
Brief Description:
The Principal Biostatistician will be responsible for performing, and validating statistical analyses in support of Medical Affairs, inclusive of overseeing the work of statistics and programming for external vendors as needed and sit within the Medical Affairs Statistics, Epidemiology and RWE branch of the Data Sciences department. They will build relationships with other Medical Affairs’ functions to effectively collaborate on activities that may involve real world elements. Learn key clinical and life cycle management considerations, to ensure that planned statistical methods are applicable and optimal, and communicate statistical perspective to stakeholders. Be able to advise on analytic strategies and recommend methodological solutions appropriate for integrated evidence generation research.
Essential Functions
- Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of client products.
- Contribute to publication objectives including timelines, statistical and analytical requirements for publications and projects.
- Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
- Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
- Review publications, marketing materials, and education and training materials that contain clinical data and product claims
- Stay informed with data being generated in current clinical development programs
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
- Collaborate and provide statistical support to the HEOR group in relevant areas including HTA and NTAP submissions.
- Develop real world evidence strategies utilizing real-world data assets to design and execute RWE research projects, including the development of protocols and statistical analysis plans, in collaboration with epidemiology and RWE leadership team.
- Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities.
Minimum Requirements
- Master’s degree with >2 years of experience; OR PhD in statistics, mathematics or a related discipline with a statistical focus.
- Proficient in drug development regulations pertinent to statistical analysis
- Proficient SAS & R programming skills
- Understanding of CDISC SDTM and ADAM models and standards is preferred, but not required.
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.
- Able to work in a fast-paced, flexible, team-oriented environment.
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $70-$82 per hour, can vary depending on employment status.
- Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
