Principal Biostatistician FSP (Launch/HTA)

Cytel; Toronto; On-site; CAD 85,000 - 110,000; Full time

Job summary

A leading biostatistical consultancy in Toronto seeks a Senior Biostatistician to support Health Technology Assessment (HTA) and launch activities for a major pharmaceutical client. Ideal candidates have a master’s in statistics and over 5 years in drug development, with strong SAS and R programming skills, as well as a flexible and customer-oriented mindset. This role involves statistical support, publication delivery, and collaboration across teams, offering a great opportunity to contribute to innovative patient treatments.

Benefits

Consistent training and development

Support for career success

Qualifications

• 5+ years supporting drug development or launch/post-marketing activities in the Pharmaceutical or Biotechnology industry.
• Experience with launch/HTA activities and/or economic modelling is strongly desired.
• Effective communicator able to explain methodology and consequences in lay terms.

Responsibilities

• Providing statistical support to our customer's launch and HTA activities.
• Contributing to the concept, planning and delivery of scientific publications related to new products.
• Collaborating with internal and external functions to ensure meeting project timelines.

Skills

Statistical support

SAS programming

R programming

Communication skills

Team collaboration

Education

Master’s degree in statistics or related discipline

Ph.D. (desirable)

Tools

CDISC requirements

HTA dossiers

Job description

Who Are You?

An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's HTA and launch activities. You are motivated to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

This role is to support our customer's Health Technology Assessment (HTA) and launch activities. Having exposure to this area is a bonus, and will enable collaborating effectively, with colleagues from the different functions involved. Strong statistical skills and a flexible, customer-oriented mindset, but in full adherence to good statistical principles, will make you an asset for this role.

As a Senior Biostatistician, your responsibilities will include:

• Providing statistical support to our customer's launch and HTA activities
• Contributing to the concept, planning and delivery of scientific publications related to new products launched by our customer
• Supporting the planning compilation of HTA dossiers as appropriate
• Support Economic Modelling as appropriate
• Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
• Understand and follow applicable guidelines in different regions.
• Collaborate with internal and external functions (e.g. CROs, programming clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical practices

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• Master’s degree in statistics or a related discipline. Ph.D. is desirable.
• 5+ years supporting drug development or launch/post-marketing activities in the Pharmaceutical or Biotechnology industry.
• Experience with launch/HTA activities and/or economic modelling is strongly desired.
• Good SAS and/or R programming skills with application to these fields for generation and QC of deliverables and exploratory activities/modelling
• Solid understanding & implementation of CDISC requirements for regulatory submissions.
• Full commitment to driving effective delivery and contributing to the strategic goals of the customer's project/product teams
• The ability to build strong external & internal relationships and motivate a regional or global team.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• If you possess German language skill at a native or near-native level, this will create additional opportunities for involvement in the customer's German HTA dossiers.

Cytel Inc. is an Equal Employment / Affrecative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.