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At-a-Glance:
Are you ready to build your career by joining a global pharmaceutical company? If so, our client is hiring a Sr. Biostat Programmer!

In this exciting opportunity, you will support the Biostatistics team by carrying out the programming activities of statistical programmers and working closely with clinicians, programmers, study teams, and publication managers to generate outputs. You will also ensure timely and accurate programming and validation activities for clinical studies and publications.

Core Accountabilities:

• Providing statistical programming and validation support for clinical study reports and publications. Overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas:
  • SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests.
  • Work with the clinical study team on study design, development, and/or review of clinical study protocols.
• Develop and/or review statistical analysis plans, including Table/listing/figure shells and final study report for clinical studies.
• Perform post-hoc statistical analyses as needed.
• Work closely with clinicians, statisticians, and publication managers to generate publication QC outputs.
• Review publications (abstract/manuscripts) to ensure statistical methodologies' accuracy, quality, and soundness.
• Work with the project statistician and clinical data managers on the design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT).
• Generate/review data tables/listings, and coordinate data review meetings during the study to ensure data quality.
• Providing input to the Database and CRF Development, creating edit check programs, and providing feedback to the Data Management.
• Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
• Work independently to accomplish tasks and goals defined by the supervisor and bring in new ideas to improve the programming process and maintain standards for programming activities.
• Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables and may work on submission teams as a statistician and/or a programmer.

Skills & Background:

• MS in Biostatistics/Statistics preferred, with at least 7 years of experience in the pharmaceutical, CRO, or biotech industry.
• Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH.
• Strong CDISC data standards knowledge, e.g., SDTM and ADaM
• Robust technical writing knowledge.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
• Strong submission experience.
• Ability to work independently.

Approx. Duration: 12 months.

Get in Touch
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Shekhar at 201-822-3519 to learn more.

Who We Are
Since 1986, Hired by Matrix, Inc. has improved our candidates' lives with exciting job opportunities that provide outstanding career advancement. Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days, and a 401k option with a company match after one year.

Hired by Matrix is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business.