Job Description

Leading biotech focused in metabolic and endocrine disorders and home based on the West coast is actively looking to bring a Biostatistician onto their team!

Description:

This individual will collaborate with lead programmer, clinical data manager, CRO vendors, and other colleagues in the creation, implementation, and maintenance of statistical deliverables for each project. The candidate will lead the effort to continuously improve processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives.

Roles and Responsibilities

• Perform duties of a Project/Study Statistician to support clinical projects/trials (both early stage and phase II and III).

• Provide expertise towards the planning of study designs, data collection, data monitoring and results interpretation.

• Prepare statistical methodology sections for protocols and Statistical Analysis Plans (SAPs) with minimum support from Statistics Management

• Manage CRO oversight with minimum supervision from Statistics Management to ensure the quality and timeliness of deliverables from the CRO.

• Propose and perform other ad-hoc statistical activities as needed for both internal and external requests including publications and information requests from regulatory agencies, and as needed analyses to support an FDA advisory committee or other regulatory meetings.

• Provide leadership and support to project teams on all statistical and data programming matters according to the projects\' strategies.

• Communicate regularly with CRO vendors to ensure quality and on-time delivery, as well as with members of various internal teams (Data Science, Medical Science, and Program Development) to provide delivery-related updates.

• Lead projects for all Statistical deliverables through the project milestones, from study start-up to regulatory submission.

• Lead design, development, and validation of CDISC ADAM Specifications and submission package.

Additional Skills & Qualifications:

• MS in statistics, computer science, mathematics, engineering, or life science with 4+ years of industry experience in the pharmaceutical industry, or BS in statistics, computer science, mathematics, engineering, or life science with 6+ years of industry experience in the pharmaceutical industry.

Preferred Qualifications

• Good statistical knowledge and experience in all phases of drug development including trial design.

• Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.

• Experience in ad hoc analysis/programming.

• Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).

• Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We\'re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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