Principal Biostatistician (Medical Affairs - North America & Europe)
Syneos Health, Inc., Florida, New York, United States
Overview
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 we do. We constantly simplify and streamline our work to make Syneos Health easier to work with and more engaging for our employees.
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 a Total Self culture – where you can authentically be yourself. Our culture unites us globally and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with. By bringing together diversity of thought, backgrounds, cultures and perspectives, we create a place where everyone feels they belong.
Job Responsibilities
Lead and mentor biostatisticians in job skills and oversee or develop training plans or materials for biostatistics associates; conduct training sessions and enhance the skills of new hires and existing personnel.
Prepare Statistical Analysis Plans (SAPs) and develop well‑presented mock‑up displays for tables, listings and figures; collaborate with sponsor as required.
Carry out the statistical aspects of the protocol, generate the randomization schedule and contribute input to the clinical study report.
Review SAS‑annotated case report forms (CRFs), SAS database design and other study documentation to ensure protocol criteria are met and all data are captured as needed for a high‑quality database and analysis.
Create or review programming specifications for analysis datasets, tables, listings and figures.
Direct the activities of other biostatistics personnel on assigned projects; provide independent review of their work.
Implement company objectives and create alternative solutions to address business and operational challenges.
Represent biostatistics on project teams and interface with other departmental project team representatives; prepare in advance for internal meetings, contribute ideas and demonstrate respect for others’ opinions.
Perform verification and quality control of project deliverables, ensuring they meet the expected results and are consistent with the SAP and specifications.
Manage scheduling and time constraints across multiple projects, set goals based on priorities, discuss time estimates, adapt to timeline or priority changes, and communicate proactively to biostatistics management.
Provide statistical programming support as needed.
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.
Lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
Provide input and review, and follow applicable SOPs, work instructions (WIs) and relevant regulatory guidelines (e.g., ICH).
Maintain well‑organized, complete and up‑to‑date project documentation, verification/quality control documents and programs; ensure inspection readiness.
Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.
Support business development activities by contributing to proposals, budgets and attending sponsor bid‑defense meetings.
Perform other work‑related duties as assigned.
Travel may be minimal.
Qualifications
Lead experience within Medical Affairs is required.
Must be located in Europe or North America.
PHD required.
Prior experience in biostatistics and leadership roles.
Strong knowledge of statistical programming (SAS).
Excellent communication and interpersonal skills.
Benefits Benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible paid time off (PTO) and sick time.
EEO Statement 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 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, please contact us at jobs@syneoshealth.com.
Contact Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373
Visit http://www.syneoshealth.com for more information.
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Our Clinical Development model brings the customer and the patient to the center of everything we do. We constantly simplify and streamline our work to make Syneos Health easier to work with and more engaging for our employees.
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 a Total Self culture – where you can authentically be yourself. Our culture unites us globally and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with. By bringing together diversity of thought, backgrounds, cultures and perspectives, we create a place where everyone feels they belong.
Job Responsibilities
Lead and mentor biostatisticians in job skills and oversee or develop training plans or materials for biostatistics associates; conduct training sessions and enhance the skills of new hires and existing personnel.
Prepare Statistical Analysis Plans (SAPs) and develop well‑presented mock‑up displays for tables, listings and figures; collaborate with sponsor as required.
Carry out the statistical aspects of the protocol, generate the randomization schedule and contribute input to the clinical study report.
Review SAS‑annotated case report forms (CRFs), SAS database design and other study documentation to ensure protocol criteria are met and all data are captured as needed for a high‑quality database and analysis.
Create or review programming specifications for analysis datasets, tables, listings and figures.
Direct the activities of other biostatistics personnel on assigned projects; provide independent review of their work.
Implement company objectives and create alternative solutions to address business and operational challenges.
Represent biostatistics on project teams and interface with other departmental project team representatives; prepare in advance for internal meetings, contribute ideas and demonstrate respect for others’ opinions.
Perform verification and quality control of project deliverables, ensuring they meet the expected results and are consistent with the SAP and specifications.
Manage scheduling and time constraints across multiple projects, set goals based on priorities, discuss time estimates, adapt to timeline or priority changes, and communicate proactively to biostatistics management.
Provide statistical programming support as needed.
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.
Lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
Provide input and review, and follow applicable SOPs, work instructions (WIs) and relevant regulatory guidelines (e.g., ICH).
Maintain well‑organized, complete and up‑to‑date project documentation, verification/quality control documents and programs; ensure inspection readiness.
Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.
Support business development activities by contributing to proposals, budgets and attending sponsor bid‑defense meetings.
Perform other work‑related duties as assigned.
Travel may be minimal.
Qualifications
Lead experience within Medical Affairs is required.
Must be located in Europe or North America.
PHD required.
Prior experience in biostatistics and leadership roles.
Strong knowledge of statistical programming (SAS).
Excellent communication and interpersonal skills.
Benefits Benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible paid time off (PTO) and sick time.
EEO Statement 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 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, please contact us at jobs@syneoshealth.com.
Contact Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373
Visit http://www.syneoshealth.com for more information.
#J-18808-Ljbffr