Systems Analyst Ii

3+ years

Not Disclosed

Bangalore

12 June 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Seeking a Systems Analyst (internally referred to as SAS Programmer) to Create, maintain and test code used for non-standard data file creation as well as for CDISC SDTM and ADaM datasets; mentor System Analyst I staff; programming resource for Clinical Data Operations staff and other departments as needed including creation of statistical and submission-ready datasets.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Attend client meetings as appropriate to understand data collection requirements for the protocol.
Receive and review standard Clario/non-Clario standard client file specifications from Data Manager/Project Manager or client and interact with the client to finalize transfer specifications.
Develop and validate programs to create non-standard data files as well as CDISC SDTM and ADaM compliant datasets.
Create submission-ready datasets for cardiac safety trials (SDTM EG and ADaM ADEG) including define.xml and dataset reviewers guides for FDA submissions.
As part of the Software Development Life Cycle, develop and unit test code, create and execute test scripts and perform peer review.
Process data extracts, review encoding requests daily to run encoding programs and archive studies.
Performing ad-hoc programming activities utilizing raw data based on internal and external requests for:
- Esoteric quality control checks.
- Data resolution/mining.
- Treatment emergent flags and other specifications per Statistical Analysis Plan.
- Other client requirements.
Work with data management in providing programming support for DM activities including data review.
Prepare and participate in internal and external audits.
Work across multiple service lines and modalities.
Work hand in hand with a cross functional teams (Cardiologists, Data Managers, Project Managers and other industry experts) for project delivery - for example to support New Product Initiatives and Minimum Viable Product solutions.
Identify opportunities to improve the methodology and provide practical solutions for problems.
Contribute to the development of best practice to improve quality, efficiency and effectiveness.

OTHER DUTIES AND RESPONSIBILITIES:

Assist with orientation and training of CDP and Data Management / Project Management personnel as determined by management.
Mentoring System Analyst I and other CDP resource.
Contribute to process development.
Review and development of SOPs and associated documents related to CDP activities. Maintain working knowledge of CDISC SDTM/ADaM standards and recommend changes to processes and standard specifications as needed.
Complete administration tasks as needed within CDP.

QUALIFICATIONS AND SKILLS NEEDED:

SAS Certified Specialist: Base Programming.
SAS Certified Professional: Advanced Programming is a plus.

Education:

Bachelor’s or Master’s degree in Informatics, Mathematics, Computer Science or other relevant qualification.

Experience:

Ideally three or more years of experience in a Pharmaceutical company or a CRO as a SAS Programmer - experience in SAS/BASE, SAS/MACRO and SAS/SQL products and procedures and one or more years experience in database design and data structures.
Understanding of the pharmaceutical drug development process, as gained through a minimum of two years experience in the pharmaceutical or healthcare industry.
Proven experience working with large, complex, real-world data sets (more specifically patient data).
Extensive experience in implementing CDISC SDTM and Define standards. Working knowledge of EG, CO, RE and QS CDISC domains would be valuable.
Knowledge of technical and regulatory requirements related to the role.
Excellent time management skills, contributing to multiple projects with competing timelines.
Strong written and verbal communication skills Fluency in English (spoken and written).
Assist in developing and delivering training.
Experience with Windows and Microsoft Office products.
Experience with DB programming is a plus.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.