Biostatisticien(ne) principal(e) FSP, Phase tardive

Role Summary

• Job Title: Senior Biostatistician FSP, Late Phase
• Job Location: Kirkland, Canada
• Job Location Type: Home-based
• Job Contract Type: Full time

French Job Description

Position level: Senior FSP biostatistician, late phases

Location: Work from home in the United States or Canada

Why DSSS?

Data Sciences Staffing Solutions, DS3, is a unit within IQVIA that provides our sponsors with fully integrated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for a leading global CRO while collaborating with sponsor teams and using sponsor systems. These sponsor clients include world-class pharmaceutical and biotechnology companies that provide you with unique opportunities to influence the future of medicine and advance therapies in the marketplace.

The Senior Biostatistician is responsible for providing statistical support to phase 2 or 3 drug development programs with efficacy and safety criteria.

English Job Description

Job Level: FSP Senior Biostatistician, Late Phase

Location: Home-based in the U.S. or Canada

Why DSSS?

Data Sciences Staffing Solutions, DS3, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership.

This means you get all the benefits of working for an industry leading global CRO while collaborating with sponsor teams and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

The Senior Biostatistician is responsible for providing statistical support for drug development programs in phases 2 or 3 with efficacy and safety endpoints.

Responsibilities

• Collaborate with multidisciplinary project teams to establish project timelines.
• Provide statistical data to study synopses and protocols.
• Write or revise the statistical sections of clinical trial protocols, while consulting internal and external experts.
• Write or revise statistical analysis plans, datasets and TLF specifications.
• Provide guidance and supervision to programmers in writing analysis data set specifications and programming tables, lists and figures.
• Effectively manage internal and project CRO activities, including timelines, deliverables and resource availability.
• Collaborates with data management, statistical programming and clinical development, with statistical expertise.
• Use SAS and/or R to perform inferential analyzes and validate derivations of important data.
• Support exploratory analyzes and publications.
• Contributes to clinical study reports and other regulatory documents, e.g. DSUR, information documents, benefit-risk analyses, IB, etc.
• Participate in NDA and related activities.
• Participates in activities and meetings to support biostatistics and the development team.
• Demonstrated ability to work independently, manage projects and make decisions.
• Able to communicate statistical concepts effectively.
• Compliance with SOPs and best practices to ensure quality work product.

Qualifications (minimum acceptable level of education, work experience and skills)

• PhD in statistics, biostatistics or related field with 3 or more years of industry experience.
• MS in Statistics, Biostatistics or related field with 5 or more years of industry experience.
• Understanding of ICH and FDA guidelines as well as general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, ADaM, CDASH.
• Collaborate with multidisciplinary project teams to establish project timelines.
• Provide statistical input to study synopses and protocols.
• Writes or reviews the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Write or review statistical analysis plans, dataset and TLF specifications.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
• Effectively manage internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborates with Data Management, Statistical Programming and Clinical Development, with statistical expertise.
• Use SAS and/or R to perform inferential analyses and validate important data derivations and TFL.
• Support exploratory analyses and publications.
• Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, Benefit-Risk analyses, IB, etc.
• Participate in NDA and related activities.
• Participates in activities and meetings to support Biostatistics and the Development Team.
• Demonstrated ability in working independently, project management and decision making.
• Able to effectively communicate statistical concepts.
• Compliance with SOPs and best practices to ensure quality work product.
• Qualifications (Minimal acceptable level of education, work experience, and competency)
• PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• Understanding of ICH and FDA Guidance as well as general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, ADaM, CDASH.

Requirements

Desired experience

• Knowledge of simulations, multivariate analyzes and biomarker analyzes
• Experience in various therapeutic areas
• Programming for producing statistical results
• Regulatory submission activities
• Estimation framework

"This is posted in anticipation of a future role"

Desired Experience

• Knowledge of simulations, multivariate analyses, and biomarker analyses
• Experience in a range of therapeutic areas
• Production programming of statistical outputs
• Regulatory submission activities
• Estimand framework

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au , afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.

• IQVIA s’engage à faire preuve d’intégrité dans son processus de recrutement et applique une politique de tolérance zéro en matière de fraude des candidats. Toutes les informations et toutes les qualifications soumises dans votre candidature doivent être véridiques et complètes.
• Any misrepresentation, misleading presentation or material omission during the recruitment process will result in immediate disqualification of your application, or termination of employment if later discovered, in accordance with applicable laws. We appreciate your honesty and professionalism.
• Please note that we may use artificial intelligence (AI) in processing your application. However, we use AI only to help our recruiting team screen or evaluate candidates, and not to replace decision-making by our team members.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: , so that IQVIA can support your participation in the recruitment process.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidates, and not as a substitute for human decision-making.

The potential base salary range for this position, annualized, is $110,400.00 - $221,500.00. The actual base salary offered may vary depending on several factors, including job-related qualifications such as knowledge, skills, training and experience; location; and/or schedule (full-time or part-time). Depending on the position offered, incentive plans, bonuses and/or other forms of compensation may be offered, in addition to a range of health, wellness and/or other benefits. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; rental; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.

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Benefits

Additional benefits

• Remote work from home opportunities
• Work/life balance as well as flexible hours.
• Collaborate with motivated and efficient research and statistics teams
• Technical training and personalized development program
• Research opportunities that match your unique skills
• Promising career trajectory
• Job stability: long-term commitments and redeployment opportunities
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging and fast-paced environment
• Good work-life balance
• Additional Benefits
• Home-based remote working opportunities
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high-performance, statistical and research teams
• Technical training and tailored development curriculum
• Research opportunities that match your unique skillset
• Promising career trajectory
• Job stability: long-term engagements and re-deployment opportunities
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast-paced environment
• Good work-life balance
• “This post is being posted in anticipation of a future role.”