What are the responsibilities and job description for the Director, Clinical Biostatistics position at Exokeryx, Inc.?

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values :

RETHINK CONVENTION : We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
AIM HIGH : We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
LEAD WITH HEART : Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
MODEL EXCELLENCE : The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary :

Reporting into the Vice President of Clinical Development, the Director of Clinical Biostatistics will provide statistical support and oversee statistical consultant / CRO services for Vaxcyte clinical programs, including the design of protocols, development of statistical analysis plans, analysis of trial data, and drafting and review of clinical study reports and manuscripts for publication. The Director of Clinical Biostatistics will also provide strategic input and statistical support for regulatory submissions and auxiliary studies.

Essential Functions :

Provide statistical support and oversee statistical activities contributing to the design of clinical trials, including statistical methodology and determination of sample sizes, estimands, and randomization schemes.

Contribute to and provide expert review of clinical protocols, statistical analysis plans, and clinical study reports.

Provide strategic input to and statistical support for regulatory submissions, including integrated summaries of safety and efficacy, Investigator’s Brochures, annual reports, and responses to regulatory agencies.

Provide oversight of, and maintain effective working relationships with external biostatistics vendors, including monitoring of statistical activities during the conduct of clinical studies.

Work with clinical quality assurance on the development of SOPs to ensure that data analysis and data reporting are in compliance with regulatory requirements, industry standards and best practices.

Stay current on emerging trends, advances, and regulatory guidance related to biostatistics and vaccine development.

Co-author abstracts, posters, presentations, and publications.

Play an active and productive role on multifunctional program and study teams.

Requirements :

Ph.D in Statistics, with a minimum of 8 years of industry experience, including 5 years supporting Phase 1-3 vaccine clinical trials.

Advanced knowledge of biostatistics and clinical trial methodology.

Strong knowledge of statistical software programming with SAS and / or R.

Excellent written and oral communication skills to meet the needs of varied audiences.

Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies are desirable.

Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.

Demonstrated ability to manage multiple projects simultaneously, effectively prioritize tasks, and ensure timely completion in a fast-paced environment.

Ability and willingness to travel up to 10-15%.

For remote candidates : ability to work primarily remotely.

Must have legal authorization to work in the United States or Switzerland. Fully remote candidates in these locations will be considered.

Reports to : Vice President, Clinical Development

Location : San Carlos, CA

Compensation : The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range : $244,000 – $262,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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Salary : $244,000 - $262,000

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Director, Clinical Biostatistics

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