As a Biostatistician at Innovaderm you will provide statistical input into Phase I - IV clinical trial development, be responsible for the Statistical Analysis Plan, support the analysis of clinical trial data, and provide statistical input into clinical study reports (CSRs).
This role will be perfect for you if:
- You have deep knowledge of biostatistics methodology and pharmaceutical industry standards (ICH, FDA and Health Canada guidelines).
- You enjoy bringing a unique expertise within a project and you love explaining complex statistical concepts in a way that can be understood by colleagues, collaborators and clients.
- Working on multiple projects, including various statistical analysis techniques interests you.
- Providing statistical input into protocol and case report form (CRF) development e.g.,
- trial design,
- sample size estimation,
- planned statistical analyses,
- edit checks for clinical trial data.
- Communicating with clients regarding study protocol or statistical analysis issues and explain complex statistical concepts to non-statisticians.
- Writing detailed statistical analysis plans including table, listing and figure (TLF) mock shells.
- Reviewing annotate 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.
- Reviewing TLFs to ensure validity of the statistical results and consistency of the results across TFLs
- May analyze clinical trial data producing accurate results representing the outcome of the trial and validating statistical outputs.
- Providing support to scientific writers working on CSRs to ensure accurate interpretation of the statistical results.
- Taking on the key statistical responsibility in the planning and preparation of regulatory submissions as required.
- 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.
- Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied statistics training relevant to the clinical trials or health research environment.
- 3-5 years of biostatistical experience in the clinical trials.
Knowledge and skills
- Master’s degree or PhD in Statistics, Biostatistics, or a related field
- Deep knowledge of the ICH, FDA, and Health Canada guidelines for the pharmaceutical industry
- 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;
- Strong verbal and written communication skills in French and English;
- Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.
The work environment
At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As a Biostatistician at Innovaderm, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
- Ongoing learning and development
This role would preferably be based in our office in Montreal; however, there is a possibility to work from home according to the level of experience
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, Innovaderm continues to grow and expand in North America.
We thank you for your application and please note that only those selected for an interview will be contacted.
Innovaderm only accepts applicants with a work permit for Canada.