Biostats Consultant

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Apex Systems
Consultant, SAS, Systems
Full Time

Job Description

Biostats Consultant 1178785

Job Scope & Purpose:

Our Cambridge based client is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. They are seeking to hire a Biostats Consultant to lead statistical and programming activities in Phase I-III clinical studies. This role can be remote.

Primary Job Responsibilities:
  • Lead statistical and programming activities in ISS/ISE to support BLA
  • Perform, advise, and review protocol development, sample size calculation, protocol and CRF review
  • Ensure the accurate programming of SAS clinical data extracts and data displays
  • Provide statistical input into and perform review of SAPs, table shells, programming and table specifications, TLFs, and statistical sections for integrated reports, statistical sections of CSRs, database design, validation checks and critical data, and data review
  • Advise on regulatory issues including integrated summaries of efficacy and safety
  • Perform statistical analyses, including hypothesis testing and modeling.
  • Provide input to project timelines, and ensure that project timelines for biostatistics deliverables are met by internal and external clients.

Primary Job Requirements:
  • BS/MS degree or advanced degree in biostatistics/statistics (or similar) and 6+ years of clinical research and drug development experience.
  • Broad and thorough understanding of statistical principles, particularly with respect to statistical methodology with observational/real world data
  • In-depth knowledge of applicable clinical research regulatory requirements
  • Advanced knowledge of statistical methods , especially that apply to GI/Infectious disease focused clinical trials
  • Strong working knowledge of SAS programming
  • Prior BLA experience is desired

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity 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 us.

asobel@stratacuity.com

Code: ClinOps

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 employeeservices@apexsystemsinc.com or 844-463-6178.


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1178785
Originally Posted : 2 months ago

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