Sr Biostatistician - Neurology (Europe and LATAM only)

Syneos Health; Milano; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A global biopharmaceutical solutions organization is seeking a Sr Biostatistician - Neurology to oversee statistical tasks and mentor junior staff. This mid-senior level role in Milan requires at least 5 years of relevant experience, particularly in Neurology clinical trials. Candidates should hold a PhD in Statistics or a related field, with strong expertise in SAS. The position offers the opportunity to manage multiple projects in a dynamic environment with a focus on improving health outcomes.

Servizi

Career development opportunities

Total Self culture

Diversity and inclusion initiatives

Competenze

• Minimum of 5 years of experience in Biostatistics.
• Strong understanding of statistical analysis plans.
• Experience in Neurology clinical trials is required.

Mansioni

• Oversee statistical tasks during the project's lifecycle.
• Mentor junior biostatisticians.
• Manage multiple clinical trial projects.

Conoscenze

Clinical trial lead experience

Statistical programming

Mentoring skills

Formazione

PhD in Statistics or related field

Strumenti

SAS

Descrizione del lavoro

Sr Biostatistician - Neurology (Europe and LATAM only)

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Description

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.

WORK HERE MATTERS EVERYWHERE

• 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

• This role is open to Europe (excluding Switzerland) or LATAM (ARG, BRA, COL, MEX)
• Please submit all CVs in English
• Previous clinical trial lead experience within Neurology within industry is required

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 enhances the skills of existing personnel.

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. Collaborates with sponsor, if required.

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 and all 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.

Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.

May lead complex 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 related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.

Monitors progress 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 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.

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.

Minimal travel may be required.

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.

Summary

Sr or Principal Biostatistician - Neurology

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Research, Analyst, and Information Technology

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