Principal Biostatistician Job Description
Key Responsibilities:
* Serves as a statistical resource, mentors biostatisticians on job skills and develops training plans for Biostatistics associates.
* Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
* Provides support across all statistical tasks during the project lifecycle, from protocol to CSR.
* Prepares or oversees the preparation of Statistical Analysis Plans (SAPs) including development of well-presented mock-up displays for tables, listings, and figures.
* May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule and input to the clinical study report.
* Collaborates with sponsors as required.
* Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
* Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high-quality database and the planned analysis.
* Implements company objectives and creates alternative solutions to address business and operational challenges.
* Represents Biostatistics on project teams, interfaces with other departmental project team representatives.
* Conducts and participates in verification and quality control of project deliverables ensuring that output meets expected results and is consistent with analysis described in the SAP and specifications.
* May lead complex or multiple projects and attend regulatory agency meetings or responds to questions as needed to support the statistical analysis results of clinical trials on behalf of the sponsor.
* Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management discusses time estimates for completion of study-related activities with biostatistics management adapts to timeline or priority changes by reorganizing daily workload and proactively communicates to biostatistics management any difficulties with meeting these timelines.
* Monitors progress on study activities against agreed-upon milestones and ensures the study timelines for project deliverables are met.
* Identifies out-of-scope tasks and escalates to management.
* Provides statistical programming support as needed.
* Participates in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities including charter development and serving as an independent non-voting biostatistician.
* May serve as a voting statistician on DSMBs and/or DMCs.
* Provides input and reviews and subsequently follows applicable SOPs WI's and relevant regulatory guidelines.
* Maintains well-organized complete and up-to-date project documentation and verification/quality control documents and programs ensuring inspection readiness.
* Displays willingness to work with others assists with projects and initiatives as necessary to meet the needs of the business.
Required Skills and Qualifications
Main Requirements:
* Must have previous experience with Medical Affairs and/or HEOR and HTA.
* Graduate degree in biostatistics or related discipline.
* Extensive experience in clinical trials or equivalent combination of education and experience demonstrated by the ability to lead multiple projects and programs of studies.
* Proficiency in programming.
* Ability to apply extensive knowledge of statistical design analysis relevant regulatory guidelines and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
* Experience across all statistical tasks required to support clinical trials during the project lifecycle from protocol to CSR.
* Experience with regulatory submissions preferred.
* Excellent written and verbal communication skills.
* Ability to read write speak and understand English.
Why Join Our Team?
We offer a dynamic and collaborative environment where you can grow professionally and make a meaningful impact. As a Principal Biostatistician you will be part of a talented team dedicated to delivering high-quality results and contributing to the success of our clients.
About Us
Our company is committed to excellence in providing innovative solutions and exceptional service to our clients. We pride ourselves on our values of teamwork integrity and customer satisfaction.
Contact Information
To learn more about this opportunity please visit our website or contact us directly. We look forward to hearing from you.