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Statistical Programming Statistical Programmer - REMOTE- EST Preference Newton , MA
ID: 25442

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.


The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.