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

IQVIA•Kirkland, QC

8d•Remote

About The Position

Data Sciences Staffing Solutions (DS3), a unit within IQVIA, provides fully integrated resources to sponsors 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.

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
incentive plans, bonuses, and/or other forms of compensation may be offered
a range of health and wellness and/or other benefits