Company: ClinDatrix, Inc.
Posted on: April 4, 2021
The Experience of Big. The Advantage of Value. ClinDatrix is
looking to hire a full time in-house--Manager, Biostatistics. The
ideal candidate should be located in Southern CA and work in the
ClinDatrix office. ClinDatrix is a small service provider, CRO,
located in Irvine, CA dedicated to clinical research, data
management, and statistical analyses and reporting servicing the
biotechnology, medical device, and pharmaceutical industries.
- Manage Biostatistics staff and statistical programmers as
appropriate, including but not limited to resource planning,
recruitment, performance evaluations, and training.
- Coordinate and oversee statistical analyses and programming
activities on clinical trials.
- Facilitate interaction and communication between Biostatistics
and other members of the project teams to which s/he is assigned
(Clinical, Data Entry, Medical Writing, Data Management, Safety,
Project Management, etc.).
- Represent the Sponsor, when required, in discussions and
meetings with the FDA.
- Develop study-specific Statistical Analysis Plans based upon
the protocol, clinical monitoring plan and Case Report Forms (CRFs)
to ensure that the data collected during clinical trials are
analyzed using appropriate analyses and are reported to a level
appropriate to meet regulatory requirements.
- Manage the implementation of all Statistical Analysis Plans
with the statistical programmers.
- Develop and maintain statistical/programming policies,
guidelines, and procedures (SOPs, training manuals, etc.).
- Review protocols for Biostatistics input.
- Perform Sample Size and Power Calculations.
- Conduct statistical analyses and perform SAS programming, as
- Prepare randomizations for clinical trials.
- Write statistical reports and review integrated
- Review IND/NDA submissions.
- Provide statistical consulting and education to others within
ClinDatrix, Inc. and to sponsors.
- Maintain complete and auditable documentation of all
- Provide other general duties as required to support the
company. Qualifications and Requirements
- PhD in Statistics with five or more years experience as a
clinical statistician; or a Masters Degree in Statistics with eight
or more years experience as a clinical statistician.
- One year of supervisory experience including project
management, resource planning, staff recruitment, performance
evaluations, career development, and training.
- Knowledge of FDA regulations respecting data quality and
clinical trials conduct, analyses, and reporting.
- Strong written and oral communication skills. Proven leadership
skills. Ability to work within a team environment. Ability to
manage competing priorities in a changeable environment. Ability to
handle stressful situations and deadlines. Excellent interpersonal
skills. To start the conversation, please write, fax or click--here
. Primary Sidebar Contact Us Take advantage of our value and
ClinDatrix, Inc. * 1 Ada, Suite 250 * Irvine, CA 92618 * Tel:
949.428.6600 * Fax: 949.428.1239
Keywords: ClinDatrix, Inc., Irvine , Manager, Biostatistics, Executive , Irvine, California
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