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Lead Biostatistician

Company: Syneos Health
Location: Wilmington
Posted on: August 11, 2019

Job Description:

Summary:

Acts as

the lead or back-up statistician for multiple projects with any level of

complexity. Acts as the primary contact

with the sponsor for all biostatistics related activities on assigned

projects. Helps manage clinical trials

efficiently by providing accurate and consistent information to both sponsors

and Company business/functional units.

Essential Functions:

1.

Collaborates

in the process of protocol development by choosing an appropriate study design,

including statistical methodologies, calculating necessary sample size to

achieve a pre-specified power, and writing the statistical section of the

protocol. Sample size calculations may

require some literature search to ensure that the study assumptions are

correct.

2.

Writes

and reviews Statistical Analysis Plans (SAPs) based on the protocol, including

development of well-presented mock-up displays for tables, listings, and

figures. Collaborates with sponsor.

3.

Directs

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.

4.

Participates

in project teams as Biostatistics representative, interfacing as necessary with

other departmental project team representatives.

5.

Supports

business development activities by contributing to proposals, budgets, and

attending sponsor bid defense meetings.

6.

Creates

or reviews programming specifications for analysis datasets, tables, listings,

and figures.

7.

Participates

in Data Safety Monitoring Board and/or Data Monitoring Committee activities,

including charter development and serving as an independent non-voting

statistician.

8.

Conducts

and participates in review and quality control of project deliverables,

ensuring that output meets expectations and is consistent with analysis

described in SAP.

9.

Discusses

time estimates for completion of study related activities with the Lead Statistician

or Biostatistics management and proactively communicate to the Lead

Statistician or Biostatistics management any difficulties with meeting these

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

to management.

10.

Ensures

proper study closeout by documenting and archiving study related materials

according to Standard Operating Procedures (SOPs), and/or sponsor instructions.

11.

Generates

and/or reviews randomization schedule(s) to ensure there are no errors present

and sponsor and protocol requirements are met.

Performs ongoing monitoring of actual randomization scheme applied by

IVRS/IWRS.

12.

Displays

willingness to work with others and assist with projects and business unit

initiatives as necessary to meet the needs of the business.

Other Responsibilities:

Performs other work-related

duties as assigned. Minimal travel may

be required (up to 25

).

Note:

If there are additional responsibilities that are specific to an

individual employee, department, country, or other grouping, please use the Job

Description Addendum Template.

Requirements:

MS or PhD in

Biostatistics or related field. Moderate

experience in clinical trials or equivalent combination of education and

experience. Experience in SAS

programming. Excellent knowledge of

statistical theory including experimental design, categorical data analysis,

analysis of variance (covariance), survival analysis, and non-parametric

methods. Effective written and verbal

communication skills. Ability to apply

knowledge of basic statistical design, analysis, ICH guidelines, and

programming techniques utilized in clinical research and to effectively

communicate statistical concepts.

Ability to read, write, speak, and understand English.

Disclaimer:

Tasks,

duties, and responsibilities as listed in this job description are not

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 of

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 described above.

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 obligations

imposed by the legislation of each country in which it operates, including the

implementation of the EU Equality Directive, in relation to the recruitment and

employment of its employees.

For employees in the United States ONLY

FLSA status: Exempt

Years of experience required: MS plus four (4) years of experience

or PhD plus two (2) years of experience.

Physical Requirements: Position requires: ordinary ambulatory skills

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 10-35 pounds;

arm, hand and finger dexterity, including ability to grasp and type for

prolonged periods of time; visual acuity to use a keyboard, computer monitor,

operate equipment, and read materials for prolonged periods of time; ability to

sit, reach with hands and arms, talk, and hear for prolonged periods of

time. The noise level in the work

environment is low.

Keywords: Syneos Health, Wilmington , Lead Biostatistician, Other , Wilmington, North Carolina

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