RESPONSIBILITIES

Providing expert statistical advice in the design and review of analysis and reporting plans of clinical trials, integrated summaries and other regulatory documents, investigator-initiated study proposals and independent Data Safety Monitoring Board (DSMB) data requirements

Writing statistical study design sections of clinical protocols, statistical analysis plans, mock Table and Figure Listings (TFLs), study committee data requirements, study reports and/or other reports, regulatory submission materials such as integrated summaries

Provides support to clinical trial teams and leads overall study analysis team, including coordination of SAS programmers and statistical consultants as needed

Develops project-wide strategies, conventions and procedures for analysis, contributing to processes and SOP development relevant to the position

Statistical review and authorization of protocols and amendments, including proposed investigator-initiated trials and study committee data requirements, as well as regulatory submission materials such as integrated summaries of data

Generating QC programs to check TFLs, and programming TFLs when needed

Modeling of data; sample size and power calculations

Interacting with regulatory authorities to resolve statistical issues relating to analysis and reporting of clinical trials and regulatory submissions; acting as the statistical representative at meetings with regulatory authorities

Supervising external consultants and/or CROs in the provision of programming and statistical services, including contributing to the formulation and implementation of internal and external statistical resource strategies, managing such service providers for the programming, statistical analysis and reporting of clinical trials and integrated summaries; managing the development of statistical analysis plans and mock TFLs; providing technical expertise for programming issues in working with CROs; ensuring quality programming to generate accurate TFLs coordinating peer review of statistical documents

Developing, prioritizing and meeting measurable short and long term objectives and delivering to predetermined budgets and timelines

Maintaining awareness of overall developments in the field of clinical research and in particular expertise in state-of-the-art data manipulation and statistical analyses

Maintaining excellent relationships with pharmaceutical partners and CRO partners

REQUIREMENTS

Expertise and experience in clinical trial design, statistical methodology, and analysis and reporting of clinical trial data and integrated summaries for regulatory submissions

Broad knowledge of the drug development process and clinical study designs

In-depth knowledge of statistical and sample size methodologies and software including SAS

Experience in programming and generating TFLs, and in generating QC programs to check TFLs

Experience with the supervision of CROs and consultants providing programming and statistical analysis services

Knowledge of current FDA/EMEA/ICH regulatory requirements for the statistical analysis and reporting of clinical trial data and integrated summaries for regulatory submissions

Experience in interacting with regulatory authorities on statistical issues relating to clinical trials and regulatory submissions

Masters or PhD degree with a 8-12 years related experience

Ability to set and communicate goals, overcome obstacles and achieve results within budget and timeline specifications

Organizational, interpersonal and communication abilities

Team-building and team-oriented approach; willing to contribute at all levels; high ethical standards and integrity

COMPENSATION

Very very competitive

HOW TO APPLY

Russ Howe
Russ[at]corporate.bc.ca

DEADLINE

Apr 30, 2006