Job Description
Apex Systems is looking for multiple levels of Clinical Statisticians! Must have Clinical Research Organization (CRO) or Pharmaceutical Industry experience, along with PhD or Masters degree in Biostatistics or related field. You will be utilizing SAS software, so this is also required. Please email Donna Badin at for additional consideration.
DESCRIPTION
This role is for a lead biostatistician that is primary point of contact of the analysis teams. Activities will include: Prepare analysis plans and write specifications for analysis files, tables, and figures; communicate with clients regarding study protocol or statistical analysis issues as they arise; communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results; and interpret analyses and write statistical sections of study reports.
MUST HAVE
• Experienced Biostatistician in Clinical Trials
• SDTM & ADAM experience
• SAS is the key software - need to have experience with this
• Lead experience
• At least 5 years-experience minimum in the industry
• Experience writing/reviewing (specs, data and outputs)
NICE TO HAVE
• Gastroenterology experience
• Experience with R
• Bayesian experience
• Unblinded DMC / Interim analysis experience
EDUCATION
• Masters degree in Biostatistics or other related field with at least 5 years of experience
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
•2+years CRO experience
•Excellent written and oral communication skills including grammatical/technical writing skills
•Excellent attention and accuracy with details
• In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (====P) and International Conference on Harmonization (ICH) guidelines
•Working knowledge of relevant Data Standards ( CDISC SDTM and ADaM)
•Strong individual initiative
•Strong organizing skills and able to lead coordinate small teams
•Strong commitment to quality
•Ability to effectively manage multiple tasks and projects
•Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM QUALIFICATIONS
Master's degree in biostatistics or related field and 3+ years relevant experience
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice
DESCRIPTION
This role is for a lead biostatistician that is primary point of contact of the analysis teams. Activities will include: Prepare analysis plans and write specifications for analysis files, tables, and figures; communicate with clients regarding study protocol or statistical analysis issues as they arise; communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results; and interpret analyses and write statistical sections of study reports.
MUST HAVE
• Experienced Biostatistician in Clinical Trials
• SDTM & ADAM experience
• SAS is the key software - need to have experience with this
• Lead experience
• At least 5 years-experience minimum in the industry
• Experience writing/reviewing (specs, data and outputs)
NICE TO HAVE
• Gastroenterology experience
• Experience with R
• Bayesian experience
• Unblinded DMC / Interim analysis experience
EDUCATION
• Masters degree in Biostatistics or other related field with at least 5 years of experience
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
•2+years CRO experience
•Excellent written and oral communication skills including grammatical/technical writing skills
•Excellent attention and accuracy with details
• In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (====P) and International Conference on Harmonization (ICH) guidelines
•Working knowledge of relevant Data Standards ( CDISC SDTM and ADaM)
•Strong individual initiative
•Strong organizing skills and able to lead coordinate small teams
•Strong commitment to quality
•Ability to effectively manage multiple tasks and projects
•Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM QUALIFICATIONS
Master's degree in biostatistics or related field and 3+ years relevant experience
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice
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