Staff Biomedical Data Manager
1325 Boylston Street, Suite 10000, Boston, MA 02215 · onsite
$109k–$167k
Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Join Us as a Senior Programmer Analyst II – Make an Impact at the Forefront of Innovation The Senior Programmer Analyst II performs advanced statistical and clinical programming activities to support clinical research projects. The role requires strong expertise in end-to-end clinical SAS programming, including SDTM, ADaM, and Tables, Listings, and Figures (TLFs). The Senior Programmer Analyst II works independently as a Lead Programmer or Study Lead on complex clinical studies, ensuring high-quality deliverables, managing study timelines, collaborating with cross-functional teams, and providing guidance and mentorship to junior programmers. What You'll Do Act as the Lead Programmer or Study Lead on complex clinical studies, working directly with project leaders and client representatives to manage programming activities, timelines, resources, and deliverables. Independently manage end-to-end clinical SAS programming activities, including SDTM dataset creation, ADaM dataset development, and generation of Tables, Listings, and Figures (TLFs). Develop, execute, maintain, and validate SAS programs to support clinical trial data analysis and reporting. Ensure compliance with CDISC standards, including SDTM and ADaM, and applicable clinical programming guidelines. Lead programming activities across clinical studies, ensuring timely delivery of high-quality datasets, analysis outputs, and supporting documentation. Collaborate with Biostatistics, Clinical Data Management, and other cross-functional teams to meet study objectives. Perform quality control and validation of statistical programming deliverables, ensuring accuracy, consistency, and regulatory compliance. Manage multiple programming assignments, prioritize deliverables, and ensure adherence to project timelines and departmental SOPs. Provide technical guidance, training, and mentorship to junior programmers. Participate in client meetings, project discussions, and programming reviews as the primary programming representative. Contribute to process improvements, programming standards, training materials, and departmental working practice documents. Support resource planning, project forecasting, and bidding activities when required. Education & Experience Requirements Master's degree in computer science, Statistics, Biostatistics, Mathematics, or a related field, with relevant clinical programming experience. OR Bachelor's degree in computer science, Statistics, Biostatistics, Mathematics, or a related field, or an equivalent relevant academic/vocational qualification. Mandatory Experience Minimum 7 years of end-to-end clinical SAS programming experience, including SDTM, ADaM, and TLF development, with proven experience independently leading clinical studies as a Study Lead Programmer. Strong hands-on experience in SAS programming, including Base SAS, SAS Macros, PROC SQL, and clinical reporting. Demonstrated experience independently managing programming deliverables across clinical studies. Experience working within the pharmaceutical, biotechnology, or CRO industry. Knowledge, Skills & Abilities Advanced proficiency in SAS programming, including Base SAS, SAS Macros, and PROC SQL. Strong knowledge of CDISC standards, including SDTM and ADaM. Extensive experience developing and validating Tables, Listings, and Figures (TLFs). Proven Study Lead or Lead Programmer experience managing complex clinical studies independently. Strong understanding of clinical trial processes, statistical programming, and regulatory requirements. Excellent analytical, problem-solving, and troubleshooting skills. Strong attention to detail and commitment to data accuracy and quality. Ability to independently manage multiple studies, assignments, and challenging timelines. Strong communication and stakeholder management skills, including the ability to interact effectively with clients and cross-functional teams
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1325 Boylston Street, Suite 10000, Boston, MA 02215 · onsite
$109k–$167k
South Africa, Remote · remote
Salary not posted
South Africa, Remote · remote
Salary not posted