Statistical Programmer

该职位来源于猎聘 This position supports work from home. JOB ACCOUNTABILITIES:

• Statistical Programming: 1) Develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRFs), and other related programming documentation (e.g., define.xml files, reviewers’ guides for SDTM and ADaM datasets) based on Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), which are compliant to the pharmaceutical clinical research industry standards, conventions, regulatory requirements, and Sponsor-specific requirements. 2) Program and validate SDTM and ADaM datasets following approved dataset specifications, these may include datasets for Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), and other data analysis and reporting needs such as ad hoc and exploratory data analyses. 3) Develop SAS programs to generate and validate statistical output reports of trial data based on the Statistical Analysis Plan and statistical TLGs mock-up shells.
• Clinical Data Acquisition and Cleaning Support: 1) Develop and test SAS programs for clinical trial database logical checks and reports for ongoing data review.
• Document data and programming information in accordance with Everest company SOPs and WIs; achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.
• Achieve a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators.
• May lead programming efforts for assigned projects.
• May participate in the development and maintenance of clinical trial data and statistical reporting standards to ensure that the company standards are up-to-date and in-line with pharmaceutical industry standards, conventions, and regulatory requirements.
• Provide technical guidance and support to less experienced Statistical Programmers in the study teams.
• Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, and the knowledge of clinical trial Sponsor-specific requirements when applicable.
• Comply to Everest company-specific and clinical trial Sponsor-specific training requirements.
• Develop and provide expertise in other programming and system administration areas when required. MAJOR DECISIONS WITHIN THE INCUMBENT’S AUTHORITY LEVEL: The incumbent may make decisions in the following areas:
• Decisions on time allocation to complete assigned projects.
• Decisions on therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer.
• Decisions on client specific programming standards/conventions/procedures for assigned clients when required. DECISIONS REFERRED TO THE NEXT LEVEL OF MANAGEMENT: The incumbent may, in consultation with a Leadership Position within the Divisions of Biometrics, Biostatistics, Statistical Operations, and Statistical Programming and other relevant functional group leaders, make recommendations on the following decisions. However, the final decision/signing authority in each of the following areas will be with the corporate designated signing officers.
• Decisions related to setting project priorities.
• Decisions related to resource availability.
• Decisions on negotiation of project timelines. LEVEL OF ACCOUNTABILITY: Effective job performance can have a major impact on the effectiveness and efficiency of the statistical programming operation. Close mentoring and supervision for the assigned study teams will greatly improve the productivity of the teams and the quality of their deliverables. The position may impact approximately 3-6 trials being conducted at any given point in time. KEY EQUIPMENT/SOFTWARE USED:
• Microsoft Word, Excel, PowerPoint, Outlook, Teams.
• SAS.
• Oracle InForm, Medidata Rave, and DFdiscover.
• Web-based clinical trial tools and technologies.
• Unix.
• UltraEdit.
• Other software as may be required. KEY JOB COMPETENCIES:
• Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
• Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesn’t show frustration when resisted or blocked; is a settling influence in a crisis.
• Creativity: Comes up with a lot of new and unique ideas; easily makes connections among previously unrelated notions; tends to be seen as original and value-added in brainstorming settings.
• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Functional and Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
• Perseverance: Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks.
• Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities. QUALIFICATIONS:
• A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences with at least two years’ experience in clinical trial statistical programming and/or data analysis and with demonstrated strong capabilities and/or sustained high level of performance as a Statistical Programmer I.