Statistical Programming Statistical Programmer - REMOTE- EST Preference Newton, Massachusetts

Orbis Clinical is seeking a Statistical Programmer located remotely in EST for a 6-month contract.

Job Title: Statistical Programmer

Location: REMOTE

Contract: 6 months w/ potential extension

Summary:

The Contractor Statistical Programmer leads Tables, Listings and Figures (TLF) and standardized dataset programming in the Statistical Programming Group.

Responsibilities:

• Reviews and understands study documents, including the Protocol, electronic case Report Forms (eCRFs) and Statistical Analysis Plans (SAPs).
• Reviews and understands raw eDTC database structure.
• Participates in Statistical Analysis Plan (SAP) development and review.
• Participates in TLF shells development and review.
• Driver of Statistical Programming projects.
• Major contributor to the development of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) dataset specifications.
• Leads projects in close partnership with Biostatisticians.
• Develops global standard macros to improve the efficiency of the Statistical Programming Group.
• Creates define.xml for regulatory submissions.
• Uses CDISC validation software to ensure SDTM and ADaM datasets comply with regulations.
• Oversees vendors for outsourced statistical programming work.
• Mentors less experienced programmers.
• Represents the Statistical Programming Group at cross functional team meetings.

Qualifications:

• > 5 years of clinical trials experience.
• BS in Mathematics, Statistics or related field preferred.
• MS/PhD in Biostatistics, Public Health or related field preferred.
• Expertise in SAS required.
• R or other statistical software a plus.
• Experience in support of electronic submissions in electronic Common Technical Document (eCTD) format a plus.
• Experience with Clinical Data Standards Consortium (CDISC) data standards SDTM and ADaM preferred.
• Experience supporting an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) a plus.
• Experience in management of Statistical Programmers a plus.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $70-$80 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.