This is an outstanding opportunity for an experienced Biostatistician to work
for the company that is known as the founder of the biotech industry, and
uses human genetic information to discover, develop, manufacture and market
biotherapeutical products that address unmet medical needs. They have
multiple products on the market and a strong pipeline of projects that
guarantee long term growth. They Require a Senior Biostatistician at their
office in San Francisco.
JOB ROLE: The Senior Biostatistician works with senior biostatistics staff and
clinical monitors on clinical development plans; the design and conduct of
clinical studies; the evaluation, interpretation, and reporting of study results;
and regulatory submissions to the FDA.
PRINCIPAL RESPONSIBILITIES include:
As part of a development assessment team, collaborating in the
preparation and review of the clinical development plan.
Providing statistically sound experimental design and data analysis
input to meet project objectives and FDA statistical requirements for assigned
clinical development projects.
Reviewing all project protocols, authoring protocol statistical
analysis sections, and generating study randomization.
Reviewing case report forms to ensure that protocol objectives
are met and project standards are maintained.
Developing study analysis plans and leading this effort for selected
Developing statistical programs as necessary to perform analyses
and prepare data displays.
Authoring results sections of the clinical study report.
Supplying statistical input for BLA submissions and in response to
Providing support for publication of clinical trial results.
Keeping abreast of new developments in statistics, drug
development, and regulatory guidance through literature review and
attendance at workshops and professional meetings.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
PhD in Statistics/Biostatistics with at least 2 years of clinical trials
Experience with statistical software packages such as SAS and S-
Sound knowledge of theoretical and applied statistics.
Sound understanding of regulatory guidelines in a pharmaceutical
Effective skills in communication and team collaboration.
BENEFITS OF THE ROLE: This Company has been nominated by two well
known publications for years in succession as a top employer in the
biopharmaceutical industry and one of the best companies to work for. They
are aware that their employees are critical to business success and are
committed to providing a great work environment with programs, services and
benefits that offer great career development opportunities and enhance their
employees personal lives.
Fforde is a uniquely specialised recruitment agency/business for the
pharmaceutical, clinical research and biotechnology sectors. For applications
please email your CV to: [log in to unmask] or speak to our
specialist consultant, Nando Rodriguez on +1 212 520 8323 who will be
pleased to give you further information and advice on your personal career
needs. Visit our website and see all our job opportunities at www.fforde-