Principal Biostatistician

Principal Biostatistician (Medical Affairs - CAN & Europe)

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Overview

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

Why 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

Only open to Canada and Europe

Previous Experience Leading Medical Affairs Clinical Studies Is Required.

• 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 make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
• Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., 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 / Education

• Required Education/Experience:
• PhD/MS in statistics or related discipline with at least 5 years of pharmaceutical experience.
• Good knowledge of pharmaceutical clinical development, together with late phase and/or post-marketing activities.
• Broad knowledge and good understanding of advanced statistical concepts and techniques.
• Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (e.g., R).
• Demonstrated strong interpersonal, communication, and writing skills.
• Working experience in clinical development such as interaction with external stakeholders.

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. The Company will determine what constitutes as equivalent to the qualifications described above. 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

Only open to Canada and Europe. Previous experience leading medical affairs clinical studies is required. Major Duties and 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 make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
• Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Adelaide, South Australia, Australia 3 weeks ago

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