Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)

Principal Biostatistician (Biomarker Analyst -EMEA and US BASED) reputed company® is a leading fully integrated biopharmaceutical solutions organization built to accelerate reputed company. 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 reputed company reputed company easier to work with, but to reputed company 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 reputed company 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 reputed company

• 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 reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a reputed company where everyone feels like they belong.

Job Responsibilities Major tasks: · Collaborates with representatives from other functions to plan, execute and analyze reputed company biomarker aspects (including genomics and devices) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an reputed company statistician · Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency reputed company and between projects · Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects · Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design reputed company analysis algorithms. · Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results. · Works independently at routine and reputed company statistical questionsand tasks. · Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments. Possible Additional Tasks:

• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
• Provides support across reputed company 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. Collaborates with sponsor, if required.
• May be responsibleas reputed company Biostatistician for the statistical aspects of the protocol, reputed company of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews reputed company annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and reputed company data is captured as required to support a high quality database and the planned analysis.
• 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
• Preparing in advance for internal meetings, contributing reputed company, and demonstrating respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistentwith analysis described in the reputed company and specifications.
• May reputed company reputed company or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study reputed company activities with biostatistics management, adapts to timeline or reputed company changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors reputed company 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.
• May participate in Data Safety MonitoringBoard (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.
• 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; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Prepares in advance for internal meetings, contributes reputed company, and demonstrates respect for opinions of others
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Performs other work-reputed company duties as assigned.
• Minimal travel may be required.

Qualifications*Strong knowledge on Biomarker evaluation, esp. In Oncology, ctDNA data, relevant parameters and underlying biology

• Graduate degree in biostatistics or reputed company discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to reputed company 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 and to effectively communicate statistical concepts.
• Experience across reputed company 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.

Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company 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 reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.syneoshealth.com 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 reputed company with reputed company obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply tot his job Apply To this Job