Company: Syneos Health
Posted on: August 11, 2019
the lead or back-up statistician for multiple projects with any
complexity. Acts as the primary contact
with the sponsor for all biostatistics related activities on
projects. Helps manage clinical trials
efficiently by providing accurate and consistent information to
and Company business/functional units.
in the process of protocol development by choosing an appropriate
including statistical methodologies, calculating necessary sample
achieve a pre-specified power, and writing the statistical section
protocol. Sample size calculations may
require some literature search to ensure that the study assumptions
and reviews Statistical Analysis Plans (SAPs) based on the
development of well-presented mock-up displays for tables,
figures. Collaborates with sponsor.
the activities of other Biostatistics personnel on assigned
projects to ensure
timely completion of high quality work.
Provides independent review of project work produced by other
statisticians in the department.
in project teams as Biostatistics representative, interfacing as
other departmental project team representatives.
business development activities by contributing to proposals,
attending sponsor bid defense meetings.
or reviews programming specifications for analysis datasets,
in Data Safety Monitoring Board and/or Data Monitoring Committee
including charter development and serving as an independent
and participates in review and quality control of project
ensuring that output meets expectations and is consistent with
described in SAP.
time estimates for completion of study related activities with the
or Biostatistics management and proactively communicate to the
Statistician or Biostatistics management any difficulties with
timelines. Monitors progress on study
activities against agreed upon milestones and
ensures the study timelines for project deliverables are met.
Identifies out of scope tasks and escalates
proper study closeout by documenting and archiving study related
according to Standard Operating Procedures (SOPs), and/or sponsor
and/or reviews randomization schedule(s) to ensure there are no
and sponsor and protocol requirements are met.
Performs ongoing monitoring of actual randomization scheme applied
willingness to work with others and assist with projects and
initiatives as necessary to meet the needs of the business.
Performs other work-related
duties as assigned. Minimal travel may
be required (up to 25
If there are additional responsibilities that are specific to
individual employee, department, country, or other grouping, please
use the Job
Description Addendum Template.
MS or PhD in
Biostatistics or related field. Moderate
experience in clinical trials or equivalent combination of
experience. Experience in SAS
programming. Excellent knowledge of
statistical theory including experimental design, categorical data
analysis of variance (covariance), survival analysis, and
methods. Effective written and verbal
communication skills. Ability to apply
knowledge of basic statistical design, analysis, ICH guidelines,
programming techniques utilized in clinical research and to
communicate statistical concepts.
Ability to read, write, speak, and understand English.
duties, and responsibilities as listed in this job description are
exhaustive. The Company, at its sole
discretion and with no prior notice, may assign other tasks,
duties, and job
responsibilities. Equivalent experience,
skills, and/or education will also be considered so qualifications
incumbents may differ from those listed in the Job Description. The
Company, at its sole discretion, will
determine what constitutes as equivalent to the qualifications
Further, nothing contained
herein should be construed to create an employment contract.
Occasionally, required skills/experiences for
jobs are expressed in brief terms. Any
language contained herein is intended to fully comply with all
imposed by the legislation of each country in which it operates,
implementation of the EU Equality Directive, in relation to the
employment of its employees.
For employees in the United States ONLY
FLSA status: Exempt
Years of experience required: MS plus four (4) years of
or PhD plus two (2) years of experience.
Physical Requirements: Position requires: ordinary ambulatory
and physical coordination sufficient to move about office
locations; ability to
stand, walk, stoop, kneel, crouch periodically for prolonged
periods of time;
manipulation (lift, carry, move) of light to medium weights of
arm, hand and finger dexterity, including ability to grasp and type
prolonged periods of time; visual acuity to use a keyboard,
operate equipment, and read materials for prolonged periods of
time; ability to
sit, reach with hands and arms, talk, and hear for prolonged
time. The noise level in the work
environment is low.
Keywords: Syneos Health, Wilmington , Lead Biostatistician, Other , Wilmington, North Carolina
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