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Job Details

Biostatistician I

Company name
Synteract, Inc

Location
Morrisville, NC

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Job Summary

The Biostatistician performs the data analysis with supervision for assigned clinical studies. Works closely with the clinical team, project Sponsor, clinical data manager, other statisticians and programmers to analyze and present the data based on Sponsor specifications. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures.

Essential Duties & Responsibilities

Maintains the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and project Sponsors, executes quality assurance procedures on work produced by others and ensures statistical analysis is being done according to specifications.

Serves as lead statistician for assigned projects, coordinates and monitors work assignment of other supporting Biostatisticians and programmers.

Creates/maintains analyses, tables/listings/figures,

Writes/Reviews Statistical Analysis Plan (including Mock tables/listings).

Reviews Case Report Forms for assigned projects to ensure data is collected appropriately to achieve the analysis defined in the protocol.

Ensures table, listing and statistical analysis programming is being done according to Sponsor specifications (where not defined, within company standards).

Creates/QC specifications for, and programs, derived data sets.

Performs programming validation and ensures all Quality Control efforts have been followed.

Assists in writing and/or reviewing Statistical Reports.

Reviews protocol, providing feedback as well as adding to the methods section and providing input on project design issues, endpoint definition and sample sizes.

Provides sample size calculation and documentation.

Generates Randomization Schedules.

Works closely with Sponsor to ensure a high quality, timely delivery of tables/listings/figures and statistical reports.

Represents Biostatistics in communication with Sponsors.

Bibliography research for statistical analysis techniques.

Degree & Experience

Master's degree or equivalent in statistics, mathematics or related field of project and some related experience or equivalent combination of education and experience.

Knowledge & Skills

SPECIFIC KNOWLEDGE

Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.

Basic proficiency in BASE SAS, or other statistical software is advantageous, but not required.

Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.

Nonverbal symbolism experience (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.

SKILLS

Good proficiency in Microsoft Word, Excel, and PowerPoint, Access.

Effective verbal and writing skills; English local language, if relevant.

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

Who We Are

Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

We are not currently accepting submissions from employment agencies for this position. Unsolicited resumes will not be considered and Synteract is not responsible for any fees related to unsolicited resumes

Authorization to work in the United States, without the need for sponsorship for a work visa now or in the future, is a condition of employment. The Company will not sponsor applicants [to this position] for work visas.

Company info

Synteract, Inc
Website : http://www.synteract.com

Company Profile

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