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Orbis Clinical is seeking a remote-based Senior/Principal Statistical Programmer.
Please note, the information below is for the Principal level role:
Job Accountabilities:
Lead projects with higher level of complexity/challenges/difficulties, and lead efforts to resolve complex statistical programming issues or problems.
Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business.
May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.
Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.
Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. Perform quality control (QC) review of these documents prepared by others.
Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.
Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) checklists.
Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.
Create SDTM and ADaM define.xml files, and table of contents. Perform QC review of these files prepared by others.
Participate and/or lead programming teams in support of product regulatory submission related activities.
Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.
Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities.
Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
Complete job-required and project-specific training. Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs.
Document data and programming information in accordance with corporate SOPs and guidelines.
Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
May lead programming efforts for assigned client clusters when required.
Qualifications:
- A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least 8 years of experience in clinical trial statistical programming
OR
- A Bachelor’s degree in the above fields with at least 10 years of experience in clinical trial statistical programming.
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for this position. 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 $155,000 to $180,000. It is possible that this position can be hired outside of this salary range based on experience.
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.
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.
