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Position Summary:
The Associate Director of Data Standards & Statistical Programming (DSSP), will be responsible for:
- Planning and tracking the statistical programming activities including SAS macro development at program level and study level.
- Coordinating tasks across multiple studies within a program collaborating with CRO, Biostatistics and Data management on key deliverables.
- Ensuring the latest CDISC standards are implemented and followed
- Designing, developing and validating computer programs to analyze clinical data. Defining departmental standards and SOPs as needed.
- Overseeing and managing the workflow of required clinical data listings, summary tables, figures and Define.xml files on the program.
- Mentor junior programmers assigned to the project.
What you'll do:
- Manage all statistical programming activities at program and study level.
- Oversee the work of programmers to ensure high quality accurate results.
- Act as a liaison between statistical programming, data management, and biostatistics and plan for optimal workflow and outcomes.
- Exercise independent judgment in developing SOPs, Work Instructions and Processes to enable production of high-quality results.
- Perform statistical analysis to enable interpretation of clinical trial results.
- Create SDTM, ADaM, SAS transport files, Define.xml, Pinnacle 21 reports and reviewer guides for electronic submissions worldwide.
- Generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
- Develop Data set specifications and review TLF Shells,
- Review Data Management Plan, Data validation plan, and edit check specifications.
- Contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trials as it relates to protocol development, case report form design, and data collection.
- Recognize inconsistencies and initiate resolution of data problems.
- Automate processes to improve programming efficiency or quality.
Compensation Details:
- Orbis Clinical 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 $100-$110 per hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:
Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.
We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.
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.
Fill out the form below to get in touch with our business development team, or call us at (781) 328-1132.
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.