Sr/Pr Biostatistician - Immunology & Inflammation

Syneos Health Careers; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical solutions organization is seeking a Sr/Pr Biostatistician to lead statistical analysis for clinical trials. The role requires at least 5 years of experience, strong skills in SAS or R, and the ability to ensure data integrity and regulatory compliance. Join a passionate team focused on changing lives through innovative therapies.

Leistungen

Career development and progression

Technical and therapeutic training

Total rewards program

Qualifikationen

• Minimum 5 years of experience in biostatistics or related field.
• Experience with late phase clinical trials.
• Strong programming skills in SAS or R.

Aufgaben

• Lead statistical analysis for clinical protocols.
• Prepare statistical analysis plans (SAPs) and review specs.
• Ensure data integrity and preparation for regulatory documents.

Kenntnisse

SAS or R

Statistical analysis

Project management

Data quality control

Ausbildung

Master's degree in Biostatistics or related field

Tools

SAS

R

Jobbeschreibung

Overview

Sr/Pr Biostatistician - Immunology & Inflammation

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

About 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.

Responsibilities

• Study lead for 1-2 protocols (late phase, phase 2-3). For phase 3, may be supporting another main statistic.
• IRT, eCRF, DMC setup, SRMP (Study Risk Management Plan).
• Prepare SAPs, tables, listings, and figures (tfls, STS); review specs.
• STS (statistical surveillance), review blinded data; participate in 2-3 STS meetings during study life; assess data, interim results, and intercurrent events as needed.
• SAS or R; may partially program efficacy analyses.
• Provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepare SAPs and ensure collaboration with sponsor when required.
• May be responsible for statistical aspects of the protocol, generation of randomization schedule, publications, and input to the clinical study report.
• Coordinate activities of other biostatistics and statistical programming personnel; provide independent review of project work.
• Create or review programming specifications for analysis datasets, tables, listings, and figures; review SAS annotated CRFs, database design, and study documentation to ensure data capture supports planned analyses.
• Conduct verification and quality control of deliverables; ensure outputs align with SAP and specifications.
• Implement company objectives and develop alternative solutions for business and operational challenges.
• Serve as biostatistics representative on project teams; prepare for internal meetings, contribute ideas, and collaborate respectfully with others.
• Manage scheduling and time constraints across multiple projects; adapt to timeline changes and communicate difficulties to biostatistics management.
• Monitor study progress against milestones; identify out-of-scope tasks and escalate as needed; provide statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.
• May lead projects involving integrated analyses; attend regulatory agency meetings or respond to questions to support statistical analysis results on behalf of the sponsor.
• Follow applicable SOPs, work instructions (WIs), and relevant regulatory guidelines (e.g., ICH).
• Maintain organized, complete, and up-to-date project documentation and verification/quality control documents; ensure inspection readiness.
• Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
• Coach and mentor other biostatistics staff; perform other duties as assigned; 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.

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 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.