Principal Biostatistician (RWE, HEOR) - North America, Europe
Syneos Health, Inc., Oklahoma City, Oklahoma, United States
Principal Biostatistician (RWE, HEOR) – North America, Europe
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.
Job Overview 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.
Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, and CT experience.
Experience with RW safety studies including healthcare claims knowledge is critical.
Required skills include: propensity score matching, knowledge and use of estimands, logistic regression, survival analysis, incident rate understanding, etc.
Knowledge of safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining and AI/ML, signal detection and other safety assessment skills will be useful.
General Experience
Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures; collaborates with sponsor, if required.
Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
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.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provides independent review of project work produced by other statisticians in the department.
Implements company objectives and creates alternative solutions to address business and operational challenges.
Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives; prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
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.
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.
Leads projects involving integrated analyses, attends regulatory agency meetings, or responds to questions as needed to support the statistical analysis results of clinical trials on behalf of the sponsor.
Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., International Conference on Harmonization (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
Graduate degree in biostatistics or a 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.
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 with regulatory submissions preferred; excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Benefits
Company car or car allowance.
Health benefits include medical, dental, and vision.
Company match 401(k).
Eligibility to participate in Employee Stock Purchase Plan.
Eligibility to earn commissions/bonus based on company and individual performance.
Flexible paid time off (PTO) and sick time.
Compliance with all applicable federal, state, and municipal paid sick time requirements.
Salary Range $95,000.00 – $175,700.00
Get to Know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com.
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Job Overview 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.
Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, and CT experience.
Experience with RW safety studies including healthcare claims knowledge is critical.
Required skills include: propensity score matching, knowledge and use of estimands, logistic regression, survival analysis, incident rate understanding, etc.
Knowledge of safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining and AI/ML, signal detection and other safety assessment skills will be useful.
General Experience
Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures; collaborates with sponsor, if required.
Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
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.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provides independent review of project work produced by other statisticians in the department.
Implements company objectives and creates alternative solutions to address business and operational challenges.
Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives; prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
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.
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.
Leads projects involving integrated analyses, attends regulatory agency meetings, or responds to questions as needed to support the statistical analysis results of clinical trials on behalf of the sponsor.
Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., International Conference on Harmonization (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
Graduate degree in biostatistics or a 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.
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 with regulatory submissions preferred; excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Benefits
Company car or car allowance.
Health benefits include medical, dental, and vision.
Company match 401(k).
Eligibility to participate in Employee Stock Purchase Plan.
Eligibility to earn commissions/bonus based on company and individual performance.
Flexible paid time off (PTO) and sick time.
Compliance with all applicable federal, state, and municipal paid sick time requirements.
Salary Range $95,000.00 – $175,700.00
Get to Know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com.
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