location_onBengaluru, Karnataka, India
watch_later Posted: Mar 06, 2024
Skills Required
Nice To Have skills
Job Description
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
- May serve as Lead Statistical Programmer on projects when needed
Other duties as assigned
CANDIDATE PROFILE
- Education Experience
- Bachelor of Science / Master of Science preferably in Statistics, health-related field, computer science or equivalent.
- Minimum 10 years of experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role.
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
- Excellent team player
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