Syneos Health

Description

Manager, Biostatistics

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

• Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. 
• May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department.
• Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching.
• Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department.
• Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff.
• Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates.
• Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges.
• Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience.
• May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents.
• May be responsible for leading or participating in projects across multiple studies or programs.
• May support business development activities.
• May participate in or lead departmental or corporate initiatives.
• Performs other work-related duties as assigned. 
• Minimal travel may be required.

Qualifications

What we’re looking for

• Graduate degree, or equivalent, in biostatistics or related discipline.
• Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility.
• Previous management experience or demonstrated leadership ability preferred.
• Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines.
• Experience with regulatory submissions preferred.
• Ability to read, write, speak, and understand English.
• Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade.

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.