Senior Biostatistician (Argentina)

Description As a Senior Biostatistician at Indero you will provide statistical input into Phase I - IV clinical trial development, be responsible for the Statistical Analysis Plan (SAP), program key results from the SAP and generally support the analysis of clinical trial data.

This role will be perfect for you if:

• You have well founded knowledge of biostatistical methodologies and are efficient in SAS©.
• Working on multiple projects, including various statistical analysis techniques interests you.
• You want to advance your career with a Canadian-owned CRO with an increasingly global reach.

RESPONSIBILITIES

• Writing detailed Statistical Analysis Plans including table, listing and figure (TLF) mock shells.
• Reviewing annotated CRFs according to the CDISC SDTM Implementation Guideline for migration to SDTM standards.
• Reviewing of specifications for analysis files (SDTMs and ADaMs) and TFLs
• Reviewing SDTM and ADaM datasets to support efficient generation of clinical trial statistical analyses.
• Creating and reviewing TLFs to ensure validity of the statistical results and consistency of the results across TFLs

Providing statistical input into protocol and case report form (CRF) development e.g., trial design, sample size estimation, randomization, planned statistical analyses, CRF, edit checks for clinical trial data.

• Providing input into general standardization efforts (e.g., statistical methodology standards, standard data presentations, etc.).

Collaborating effectively with members of clinical trial implementation teams, and keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

Requirements IDEAL PROFILE Education MSc or PhD in Statistics, Biostatistics, or a related field with some applied statistics training relevant to the clinical trials or health research environment. Experience 5 years of biostatistical experience in clinical trials. Knowledge and skills Able to efficiently write and edit SAS code for the purpose of analyzing data Highly organized and detail-oriented with effective project planning and time management skills Good verbal and written communication skills in English, French is an asset Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.

Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

Flexible work schedule / work schedule Home-based position Ongoing learning and development About Indero Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Argentina.

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