Sr Biostatistician Jobs at Syneos Health – United States (Remote)

Description

Senior Biostatistician

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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

• Provides statistical consultancy to colleagues and sponsors on clinical development plans, regulatory agency interactions, study design, sample size calculations, analysis plans, reporting of results, and regulatory submissions of results.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Provides thought leadership on complex or novel statistical techniques and study designs.
• Conducts senior review of project deliverables by ensuring that output meets expectations and is consistent with analysis described in study documents.
• May lead projects across multiple studies, programs or for an ISS/ISE, acting as the primary contact with the sponsor for all biostatistics related activities on assigned projects. May attend meetings with regulatory agencies and health authorities.
• Attends and presents at industry events to enhance the Biostatistics profile of the Company within the industry.
• Attends meetings with regulatory agencies and health authorities.
• Maintains an awareness of new statistical methodology and regulations that impact the Biostatistics department and sponsor.
• May participate in, or lead, departmental or company initiatives, or cross-department working groups.
• Provides training to the Biostatistics department on complex or novel statistical techniques. May also provide training to other internal departments. Works with Biostatistics senior leadership to develop appropriate training plans for the department.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• 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.
• Supports business development activities by contributing to proposals, requests for information, budgets, and attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.
• Up to 25% travel may be required.

Qualifications

What we’re looking for

• Graduate degree in Biostatistics or related discipline.
• Extensive experience in clinical trials and drug development related statistical analysis or an equivalent combination of education and experience demonstrated by the ability to lead multiple complex and/or global projects with teams of statististicians.
• Proficiency in programming.
• Experience with regulatory submissions preferred.
• Some management experience preferred.
• Ability to apply extensive knowledge of statistical design, analysis methodology, 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.
• Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines.
• Ability to apply in-depth knowledge of statistical design, analysis, and programming techniques used in clinical trials.
• 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.