Principal Biostatistician (Non Clinical Bio statistician)
Description
Principal Biostatistician
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, youll 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 were able to create a place where everyone feels like they belong.
Job responsibilities
Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
The Nonclinical Biostatistician primarily contributes to statistical strategies for nonclinical and clinical bioanalytical assay development. This includes: contributions to study design and protocol development consistent with internal best practices; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring internal study reports, contributions to regulatory submissions, and publications. Provides immediate troubleshooting for failing assays
The Nonclinical Biostatistician contributes to statistical strategies for GLP and non-GLP drug safety studies on an as-needed basis. These activities may include: contributions to study design and protocol review; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring peer review reports, regulatory submissions, and publications. Animal safety assessment areas include: general toxicology, immunotoxicology, genetic toxicology, and carcinogenicity studies
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 biostatisticians in the department.
Provides support across all statistical tasks during the lifecycle of the project, 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. Collaborates with sponsor, if required.
May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report
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.
May lead complex or multiple projects (e.g. submissions, integrated analyses), 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.
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.
Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
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 and assists with projects and initiatives as necessary to meet the needs of the business..
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
Performs other work-related duties as assigned.
Minimal travel may be required.
Qualifications
What were looking for
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
MS (Apply Now
Principal Biostatistician
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, youll 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 were able to create a place where everyone feels like they belong.
Job responsibilities
Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
The Nonclinical Biostatistician primarily contributes to statistical strategies for nonclinical and clinical bioanalytical assay development. This includes: contributions to study design and protocol development consistent with internal best practices; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring internal study reports, contributions to regulatory submissions, and publications. Provides immediate troubleshooting for failing assays
The Nonclinical Biostatistician contributes to statistical strategies for GLP and non-GLP drug safety studies on an as-needed basis. These activities may include: contributions to study design and protocol review; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring peer review reports, regulatory submissions, and publications. Animal safety assessment areas include: general toxicology, immunotoxicology, genetic toxicology, and carcinogenicity studies
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 biostatisticians in the department.
Provides support across all statistical tasks during the lifecycle of the project, 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. Collaborates with sponsor, if required.
May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report
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.
May lead complex or multiple projects (e.g. submissions, integrated analyses), 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.
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.
Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
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 and assists with projects and initiatives as necessary to meet the needs of the business..
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
Performs other work-related duties as assigned.
Minimal travel may be required.
Qualifications
What were looking for
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
MS (Apply Now