Sr Biostatistician (Early Phase)

Location : Spain-Europe - ESP-Home-Based (Barcelona)

Job ID : 25001945

• In order to be considered for this role you must be located in: UK, Ireland, Greece, Hungary, Poland, Romania, South Africa, Spain, Ukraine, Argentina, Brazil, Columbia, or Mexico.

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.

Job Responsibilities

• Prepares or assists in preparing statistical analysis plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with other senior biostatistics personnel as needed and with sponsor, if required.
• May act as Lead Biostatistician, and be responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• As a supporting Biostatistician, provide assistance to senior staff members in the performance of statistical responsibilities (e.g., randomization, sample size estimation). Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews 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.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Manages scheduling and time constraints across multiple projects, set goals based on priorities from Lead Biostatistician and management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to the Lead Biostatistician or 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.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• 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.
• May support business development activities by attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

• Previous Lead experience within Early Phase studies is required.
• Graduate degree in biostatistics or related discipline.
• Moderate experience in clinical trials or an equivalent combination of education and experience.
• Programming experience, preferably in a clinical trials environment.
• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

Additional Information:

Tasks, duties, and responsibilities as 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.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.