- Mentor and train junior levels of programming personnel within the Statistical Programming group
- Establish and implement programming standards and ensure compliance to Standard Operating Procedures (SOPs), guidelines and working instructions
- Remain informed of new developments in programming that are relevant to the industry and develop tools in SAS for data analysis and reporting that comply with regulatory requirements
- Develop SAS programs to produce statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP)
- Develop SAS programs to produce integrated analyses and tables for the summary sections of New Drug Applications (NDAs) including ISS and ISE
- Develop specifications (metadata files) and create SAS programs for the mapping of raw datasets to CDISC SDTM standards. Create files from metadata files and using Adobe Acrobat
- Develop SAS programs to produce analysis datasets in CDISC ADaM or other formats specified by the sponsor
- Design and implement quality control (QC) programs to ensure the quality and integrity of statistical programs which are used to generate datasets including CDISC SDTM and ADaM datasets
- Perform validation programming to ensure accuracy of TFLs and compliance with SAP and FDA regulatory requirements. Perform QC on program code and outputs produced by other team members
- Participate in the development of a library of SAS macros for use across multiple projects and in training biostatisticians and other programmers in their implementation
- Assist the Data Management Department by writing and testing edit check programs to check the data for syntax errors, logical inconsistencies, and protocol violations, and generate data listings to facilitate data review performed by the clinical data managers
- Provide input to the study team in the design of annotated case report forms in conjunction with the clinical data managers
- Maintain and modify code written by others
- Follow good programming practices, including writing code that is understandable, commented, and easy to modify
- Convert data received in other formats to SAS datasets
- Perform other duties as assigned
- Bachelor's degree required
- Bachelor's degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field preferred
- Minimum of 8 years of experience using SAS in analyses of clinical trials data
- Must have worked within and be proficient with industry standards and clinical trial terminology and methodologies
- Experience with SAS for Windows, including BASE SAS (macros, ODS, SQL), SAS/ACCESS, SAS/STAT, SAS/GRAPH
- Skilled at writing complex SAS programs designed to analyze and report clinical trial data and transforming data to CDISC SDTM and ADaM formats
- Basic knowledge of FDA/ICH guidelines
- Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems
- Proficient in written communication and ability to communicate effectively to other programmers and non-technical colleagues
- Able to prioritize time effectively based on work demands and work independently
- Able to give effective presentations to small groups such as in Statistical Programming meetings
- Knowledge of other programming languages and database management software packages is a plus
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Senior Statistical Programmer - Cambridge, United States - Prometrika
Description
PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.The Sr. Statistical Programmer will create specifications and develop SAS programs for data tabulation, analysis and reporting that comply with regulatory requirements (CDISC SDTM and ADaM), SOPs/ SAP, and lead junior level programming personnel. This is an exempt position and reports directly into the Director, Statistical Programming.
RESPONSIBILITIES
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
