Senior Biostatistics Professional

Job Title:

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• Provide expert support and functional technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects.">

Key Responsibilities include participating in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.

The Senior Biostatistician will provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. Additionally, they may provide statistical support to research or other R&D areas.

Responsibilities also include advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines.

The role is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. They will work independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision.

The Senior Biostatistician plays a critical role in driving quantitative decision making in assigned indications/program through collaborations with clinical, regulatory and other strategic functions.

This position requires strong leadership skills, ability to collaborate well with non-statistical functions, good project management and matrix leadership skills.

Required Skills and Qualifications include:

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• A Master's degree in Statistics or equivalent with 7+ years relevant work experience or Ph.D. in Statistics or equivalent with 5+ years relevant work experience">
• Fluent English (oral and written)">
• Good communication and presentation skills">
• Influences decisions that directly impact the trial/project and team ability to deliver objectives">
• Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts">
• Proficiency in use of statistical software packages (e.g. SAS, R)">
• Good knowledge of drug development and Health Authority guidelines">
• Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives">
• Good understanding of Franchise/Therapeutic Area and/or regulatory activities">
• Good project management and matrix leadership skills">
• Ability to collaborate well with non-statistical functions">
• Good business ethics">
• Commitment to Diversity and Inclusion">
• Accessibility and accommodation">

We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Benefits:

We offer a competitive salary and benefits package, including medical insurance, paid time off, and opportunities for professional growth and development.

Others:

Please note that this job description is subject to change based on the evolving needs of the organization.

Skills Desired:

Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis

Keyword:

Biostatistician