Description
Biostatistician II
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.
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 – we’re able to create a place where everyone feels like they belong.
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
What we’re looking for
- 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.
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.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
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. 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.
