Principal Biostatistician (Medical Affairs - CAN & Europe)

Principal Biostatistician (Medical Affairs - CAN & Europe)

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

Responsibilities

• Provide supports to the clinical study and / or project team on all relevant statistical matters.
• Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to ensure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
• Be accountable for all statistical deliverables related to the study : statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology; Statistical Analysis Plan; data surveillance; statistical analysis results for CSR and its appendices (TLGs and in-text tables).
• Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC).
• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan.
• Perform and / or coordinate with study programmer the production of statistical analyses; review and examine statistical data distributions / properties.
• Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and / or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
• Contribute to define and review the specific deliverables related to Transparency and Disclosure.
• Plan and track study / project activities and timelines.
• Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.

Qualifications

Additional Information

No matter what your role is, you’ll take the initiative and challenge the status quo in a highly competitive and ever-changing environment. This role is open to Canada and Europe.

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.

For more information, visit www.syneoshealth.com .

Seniority level

Employment type

Job function

Referrals increase your chances of interviewing at Syneos Health. Get notified about new Biostatistician jobs in the Metropolitan Region of Caracas.

#J-18808-Ljbffr