Principal Biostatistician (Integrated Analysis)

Location: United Kingdom-Europe - GBR-Home-Based, United Kingdom

Job ID: 25001941

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.

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

• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible as Lead Biostatistician for the 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 to ensure protocol criteria are met.
• 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.
• Conducts and participates in verification and quality control of project deliverables.
• May lead complex or multiple projects (e.g. submissions, integrated analyses).
• Manages scheduling and time constraints across multiple projects.
• Monitors progress on study activities against agreed upon milestones.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
• Maintains well organized, complete, and up-to-date project documentation.
• Displays willingness to work with others and assists with projects and initiatives.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.

Qualifications

What we’re looking for:

• Integrated analysis specific role.
• Must have prior experience with integrated analysis tasks like IASAP and TLF specification preparation.
• Deep knowledge of products - clinical development plan, specifically submission strategy.
• Independently working on ad-hoc requests from regulatory authorities.
• Methodological support for planning of Benefit/Risk analyses.
• Contributor in discussions with clinical team regarding submission planning.
• Ad-hoc support in case for publication work and requests from clinical team.

General Requirements:

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience.
• Proficiency in programming.
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques.
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project.
• Experience with regulatory submissions preferred.
• 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.

Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes as equivalent to the qualifications described above. Nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act.