Principal Biostatistician (RWE, Commercial DBs) - North America
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
Experience in the application of statistics in product development or manufacturing
-Excellent English communication skills, especially related to technical/scientific issues
-Proficient in R and JMP, data acquisition/compilation across sources
-Interpersonal/teamwork and communications skills for effective collaboration
-Strong teamwork skills
-Self-management skills
-Degree in or strong desire to learn about chemistry, biology, engineering, and pharmaceutical science
Some Examples of Statistical Activities:
-Conduct data integrity reviews to ensure accuracy and traceability of data used in analyses that were previously conducted by statisticians.
-Verify statistical output, previously generated by a statistician, by conducting the various analyses and visualizations a second time to confirm accuracy.
-Provide analysis, modeling, and visualizations of data from scientific studies
-Analyze laboratory data to assess stability of drug substance and drug product
-Create stability graphs that are suitable for regulatory submission documents
-Compile/format data from one or more data sources
-Conduct testing of automation tools as part of computer system validation
-Co-author technical reports
General Experience:
Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
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Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.
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Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
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Reviews SAS annotated case report forms (CRFs), SAS 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.
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Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
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Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other statisticians in the department.
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Implements company objectives, and create alternative solutions to address business and operational challenges.
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Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
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Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in SAP and specifications.
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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. Monitor 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.
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Provides statistical programming support as needed.
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May participate 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.
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Leads projects involving integrated analyses, attends regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
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Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs),... For full info follow application link.
