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French Job Description

Niveau du poste : Biostatisticien(ne) principal(e) ou senior FSP pour le développement clinique précoce (PK)

Lieu : Télétravail aux États-Unis ou au Canada

Résumé du poste : Le biostatisticien principal est responsable du soutien statistique apporté aux programmes de développement de médicaments en phases précoces, en particulier pour les études chez des sujets sains avec des critères d’évaluation PK et PD.

Responsabilités

- Collaborate with multidisciplinary project teams to establish project timelines.
- Provide statistical input to study synopses and protocols.
- Write the statistical sections of clinical trial protocols, including sample size calculations, while consulting with internal and external experts.
- Review eCRF and other data management documents.
- Create or review randomizations and related specifications.
- 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.
- Provide statistical review and validation of the same.
- Use SAS and/or R to perform inferential analyses and validate key data derivations.
- Interpret study results and review reports of study results for accuracy.
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
- Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK with statistical expertise.
- Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc.
- Support exploratory analyses.
- May support IND activities.

Qualifications

- 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.




- 2+ years of experience in statistical analysis of non-compartmental PK endpoints in pharmaceutical industry.
- Understanding of ICH GCP, regulatory guidance for clinical pharmacology studies and industry practices/standards.
- Experience with CDISC, including SDTM, ADaM, CDASH.
- Demonstrated ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Proficiency in SAS to perform analyses and validate important data derivations.

Desired Experience

- Knowledge of basic statistical modeling, simulations and PD/biomarker analyses.

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 on project budgets and change orders.
- Engaging, fast-paced workplace.
- Good work-life balance.

Equal Opportunity Statement

IQVIA est un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération, 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, le statut marital ou tout autre statut protégé par la loi applicable.

IQVIA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status or other protected status.

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Apply on Kit Job: kitjob.ca/job/2g925p

📌 Biostatisticien principal FSP - Développement clinique précoce (PK) (Kirkland)
🏢 IQVIA
📍 Kirkland