Statistical Programmer
Job Description
. Perform this job successfully an individual must be able to perform each essential function satisfactorily
. Generate SDTM domains, ADaM datasets, statistical analysis tables, listings, figures, andDefine.xml or Define.pdf files
. Perform quality control for SAS programs and other study documents
. Plans and carefully documents differences between programming results between programdeveloper and Statistical QC programmer
. Works with Statistician and Statistical programmer to assure results are consistent withexpectations, and Quality control procedures are followed
Qualification
. 3 years or above statistical programming experience in pharmaceutical industry, oncologyexperience is a plus
. Master’s degree in biostatistics, statistics, math, physics, public health, or related majors
.Proficient in SAS programming, especially SAS macro programming, SAS certificate ispreferrable
. Self motivated and able to resolve programming issue independently
. Good English communication skill, oral and writing
Biostatistician
The biostatistician is responsible to develop and validate/review the clinical study data andstatistical results under the management of the lead to finish the in-house and clientsprojects.
Job Description
. Provide consultation service on technically challenging issues; develop statistical bestpractices and support different therapeutic areas to adopt leading statistical methodology
. Collaborate with statistical programmers and other clinical team members in ensuring that project plans are executed efficiently with timely and high-quality deliverables
. Program to create and validate clinical datasets under CDlSC standard or study-definedstandard.
. Designs, analyzes, implements, and reports findings on targeted statistical research studies.
. Work with standard and processes teams to be responsible for documentation andtraining of macros and tools to ensure accurate use.
. Annotate Case Report Form (CRF) following FDA/CDlSC or sponsor guidelines.
. Finish and review the statistical analysis to support the analysis requests for NDA/BLA submission, publication, and medical affairs.
. Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
. XML documents and reviewer’s guides per CDiSC and FDA specifications and guidelinesusing standard tools and templates.
Qualification
. Master’s degree in Statistics;
. 36 months work experience in Database administrator or Data Analyst.
. SAS Certified Base Programmer for SAS 9
. Must know how to query databases andperform analysis, including importing and exportingraw data files, manipulating data, combining SAS data sets and creating reports. Be able touse programing languages includingSAS (Primary),R, Python, and SQL
Clinical Data Manager
Job Description
. Execute lRT systems development process from Kick-off to system go live, ongoing systemchange control, system closeout and database lock activities
.Manage clinical Data Management (DM) activities for in-house & outsourced trials inclprotocol review, CRF (Case Report Form) development, database set up, data validation, &SAE (Serious Adverse Events) reconciliation, using Oracle, Phase Forward inForm; Coordinate CRO (Clinical Research Organization) data validation (data transfer specs, data reconciliation query generation & resolution)
. Perform user acceptance testing of the database using InForm, design electronic Case Report Forms (eCRFs)
. Develop and maintain databases to collect and retain clinical data for laboratory challenge and clinical field trials for pharmaceutical and biologic veterinary compounds by following good Data Management practices
. Evaluate the protocol deviations impact on data analysis and interpretation
. Develop and implement of process to allow studies to be conducted paperless by using an Electronic Data Capture system
Qualification
.Minimum 5 years clinical data manager experience in pharmaceutical industry
. Bachelor’s or Master’s degree in data managemen, data analytics, data warehousing.computer science, software engineering, or equivalent majors
. Proactive, pragmatic, flexible, service minded and able to work under (time) pressure.
. Ability to understand and implement regulatory guidelines and company procedures
Strong interpersonal skills and self motivation
System Developer
Job Description
. Execute release cutovers, plan and coordinate events and activities
. Work with out-sourced development team, QA team, operation team, project managementteam, and extemal teams to triage issues
. Proficiently use SQL and interact with RDBMS systems like SQL Server
. Collaborate with teams using Git and JRA for version control and project management
. Take full ownership of tasks, work independently, and meet project deadinesFoster effective teamwork and communication within the development team
Qualification
. Minimum of 2 years of experience in software development
. Proven ability to write scalable and reusable code, as well as test and debug applicationsStrong experience with libraries such as pandas, NumPy, and ORM’s like SQL Alchemy is crucial
. Familiarity with Object-Oriented Programming
Strong SQL skills and experience working with RDBMS systems, particularly SQL Server
. Proficiency in using Git and JiRA for version control and project management
. Self-starter capable of working independently and taking ownership of tasks
. Excellent team player with the ability to collaborate effectively and strong communication skills