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About the Role

This position is responsible for leading projects across multiple studies or programs, acting as the primary contact with the sponsor for biostatistics related activities. It provides external statistical consultancy and serves as a departmental resource for complex statistical questions, study design, and protocol development.

Responsibilities

• Serves as a statistical department resource, mentors biostatisticians, and oversees or develops training plans or materials.
• Conducts training sessions for new hires and enhances the skills of existing personnel.
• Directs the activities of other biostatistics personnel on assigned projects.
• Provides independent review of project work produced by other biostatisticians.
• Provides support across all statistical tasks during the project lifecycle, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of mock-up displays for tables, listings, and figures.
• Collaborates with sponsor, if required.
• May be responsible as Lead Biostatician for 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.
• 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.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables.
• May lead complex or multiple projects (e.g., submissions, integrated analyses).
• Attends regulatory agency meetings or responds to questions to support statistical analysis results of clinical trials.
• Manages scheduling and time constraints across multiple projects.
• Sets goals based on priorities from management and discusses time estimates for completion of study related activities.
• Adapts to timeline or priority changes by reorganizing daily workload.
• Proactively communicates to biostatistics management any difficulties with meeting timelines.
• Monitors progress on study activities against agreed upon milestones and ensures 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.
• 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.
• Displays willingness to work with others and assists with projects and initiatives as necessary.
• 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.

Requirements

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience.
• Demonstrated 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.
• Ability 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.

Skills

• Statistical design
• Statistical analysis
• Regulatory guidelines
• Programming techniques
• SAS programming
• Statistical programming
• Communication skills

Location

• Remote

Work Type

• Full-time

Experience Level

• Principal

Education Level

• Graduate degree

About the Company

• 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.
• 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.
• We bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
• 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.
• We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.
• A career with Syneos Health means your everyday work improves patients’ lives around the world.
• Partner with the most diverse team of experts in the industry.
• Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams.
• We are partners with purpose.
• We integrate seamlessly with our customers and do what’s best for their success.
• Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Equal Opportunity

• 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.
• 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.