Principal Biostatistician (Medical Affairs - CAN & Europe) Lisboa

Principal Biostatistician (Medical Affairs - CAN & Europe)

Join to apply for the Principal Biostatistician (Medical Affairs - CAN & Europe) role at Syneos Health

Description

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, and we collaborate across Functional Service Provider partnerships and Full-Service environments to deliver therapies faster.

Why Syneos Health: we are committed to developing our people, with career development, supportive management, training, peer recognition and total rewards. We value diversity of thought and background to foster belonging.

Job Responsibilities

Only open to Canada and Europe

• Provide support to the clinical study and/or project team on all relevant statistical matters.
• Contribute
  - quality input into study design (including protocol development) and setup/conduct to ensure data are captured to answer objectives and support planned analyses.
• Be accountable for all statistical deliverables related to the study: protocol sections (including sample size, randomization, methodology), Statistical Analysis Plan, data surveillance, and statistical results for CSR and appendices.
• Coordinate with external groups (e. g. , CROs or Data Monitoring Committees).
• Work with the programming team to document and review derived variables and the quality control plan.
• Produce statistical analyses and review distributions/properties of data.
• Oversee the execution of analyses according to the SAP; contribute to interpretation and discussion of results for CSR and publications to ensure statistical integrity and regulatory compliance.
• Propose and perform exploratory/ad-hoc analyses as relevant; contribute to Transparency and Disclosure deliverables.
• Plan and track study/project activities and timelines.
• Foster productive collaborations across functions in the study team to ensure quality, efficiency and innovation.

Required Education/Experience

• Ph
  D or MS in statistics or related discipline with at least 5 years of pharmaceutical experience.
• Strong knowledge of pharmaceutical clinical development, including
  - phase and/or
  - marketing activities.
• Broad understanding of advanced statistical concepts and techniques.
• Experience in a departmental computing environment; able to perform advanced analyses using SAS and possibly other languages (e. g. , R).
• Excellent interpersonal, communication and writing skills.
• Experience interacting with external stakeholders in clinical development.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of FDA-approved drugs, 95% of EMA-authorized products, and conducted 200+ studies across 73, 000 sites and 675, 000+ trial patients.

No matter your role, you’ll take initiative and challenge the status quo in a dynamic environment. Learn more at Syneos Health.

Website: www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The company reserves the right to interpret what constitutes equivalent qualifications. This description does not create an employment contract. The information provided complies with applicable laws, including the EU Equality Directive and the Americans with Disabilities Act for reasonable accommodations.

Summary

Only open to Canada and Europe. Previous experience leading medical affairs clinical studies is required. Major duties include providing statistical support, ensuring data integrity, and coordinating with external partners.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

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