Principal Biostatistician (HEOR/HTA)

Syneos Health Commercial Solutions

1mo ago

Job
Full-time
Senior & Expert Level
Science
Research & Development
Madrid

AI generated summary

You need HEOR/HTA experience, a graduate degree in biostatistics, programming proficiency, and strong communication skills. Experience in clinical trials and regulatory submissions is preferred.
You will mentor biostatisticians, manage projects, prepare statistical plans, ensure quality control, support regulatory meetings, and contribute to business development while maintaining documentation.

Requirements

Previous experience within HEOR and/or HTA is required
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.
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 lifecycle of the project, from protocol to CSR.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.

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.
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.
Implements company objectives, and creates alternative solutions to address business and operational challenges.
As biostatistics representative on project teams, interfaces with other departmental project team representatives.
Preparing in advance for internal meetings, contributing ideas, and demonstrating 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 the SAP and specifications.
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.

FAQs

Is this position open to candidates outside of the specified countries?

No, this position is currently only open to candidates in the UK, Ireland, Greece, Hungary, Poland, Romania, South Africa, Spain, Ukraine, Argentina, Brazil, Colombia, and Mexico.

What qualifications are required for the Principal Biostatistician role?

A graduate degree in biostatistics or a related discipline is required, along with previous experience in HEOR and/or HTA.

What type of experience is necessary for this position?

Extensive experience in clinical trials or an equivalent combination of education and experience is needed, along with the ability to lead multiple projects and programs of studies.

Are programming skills required for this job?

Yes, proficiency in programming is required for this role.

Will I be involved in regulatory submissions?

Experience with regulatory submissions is preferred, and you may be involved in these processes as part of your role.

Is there potential for career development in this position?

Yes, Syneos Health is passionate about developing its people through career development and progression opportunities.

What kind of projects will I be working on?

You will be responsible for statistical tasks across all projects during their lifecycle, from protocol to CSR.

What is Syneos Health's approach to workplace culture?

Syneos Health is committed to a Total Self culture, promoting authenticity and diversity among employees.

How much travel is required for this role?

Minimal travel may be required for this position.

Are there opportunities for mentorship in this role?

Yes, you will serve as a resource and mentor for biostatisticians, overseeing training plans and enhancing the skills of existing personnel.

Syneos Health Commercial Solutions

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only 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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.