eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.
OVERVIEW
The Manager, Statistical Programming is operationally responsible to ensure the direction, planning and execution of the work of the statistical programming team. The Manager, Statistical Programming provides project leadership and programming support for clinical studies. The Manager, Statistical Programming provides guidance in implementing and executing the programming and project standards plus provide hands-on expertise in programming SDTM and ADaM datasets to support various analyses and TLG Programming.
KEY TASKS & RESPONSIBILITIES
- Determine resourcing needs per project load, deadline requirements and resource utilization
- Create or review and approve programming plans at study and project level
- Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plans, SAPs, etc.)
- Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician
- Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials
- Assist Biostatisticians by suggesting algorithms to address novel analysis requests
- Develop analysis datasets for trial level reporting and integrated safety and efficacy activities
- Program and QC data listings, summaries and Graphs as defined in SAP
- Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for all phases of clinical trial reporting
- Create submission-ready SDTM and ADaM datasets following standard industry processes
- Performs peer review of all SAS Programmers’ deliverables
- Serve as Subject Matter Expert for Statistical deliverables and lead task forces to develop complex, technical solutions for projects or business needs
- Collaborate with the project team and other Professional Services Managers to ensure the deliverables are completed on time with high quality
- Develops and maintains good working relationships with internal cross functional teams and Clients
- Develops, revises, and maintains Standard Operating Procedures and Work Instructions. Assists in the training of Standard Operating Procedures and Work Instructions
- Maintain all project documentation as required by SOP and Processes
- Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
- Champion the evolution of statistical programming through automation and advanced analytics using elluminate®.
- Lead internal initiatives focused on standards governance, coding conventions, validation frameworks, and reusable assets
- May serve as Lead Statistical Programmer on projects when needed
CANDIDATE’S PROFILE
Education & Experience
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field and/or equivalent work experience preferred
- 8+ years’ experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
- 2+ years of leadership, supervisory, or technical lead experience preferred
- Excellent knowledge of English
Professional Skills
- Strong experience in preparations for NDA filings
- Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
- Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
- Knowledge of CDISC® related data models like SDTM, and ADAM
- Experience of working on multiple clinical protocols at the same time
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Technical Skills
- Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures
- Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must
- Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate
- Strong experience in SAS programming in various phases of clinical trial
- Experience in pooled data analysis and programming
- Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values
- Experience in working with relational databases and performance tuning of SAS programming
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: https://topworkplaces.com/company/eclinical-solutions/
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
