Principal Programmer _RWD SDTM

Overview:

Demand for our Functional Service Provision is growing –we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for SDTM SME with solid programming skills with a strong focus on Real-World Data (RWD) conversion to CDISC standards. This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.This position is remote, and the successful candidate can be located anywhere in India.

Responsibilities:

Employees may be required to perform some or all of the following...

Lead and deliver SDTM mapping and conversion activities for RWD to CDISC standards

Interpret complex RWD datasets and map them to appropriate SDTM domains, variables, and controlled terminology

Develop and review ECRT packages including aCRF, Define.xml, and CSDRG

Act as a Subject Matter Expert (SME) in SDTM and CDISC standards

Work independently on complex programming tasks with minimal supervision

Collaborate cross-functionally and communicate effectively with stakeholders

Document key decisions, mappings, and discussions (PowerPoint, meeting notes, etc.)

Knowledge of FDA CRT requirements including define.xml and define.pdf

Become familiar with and follow study documentation

Ensure the principles in the Phastar checklist are followed rigorously

Archive study documentation following instructions in supplied SOPs

Act as a Lead Programmer, ensuring quality and timely delivery

Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables

Assess and monitor study level resources

Point of contact for programming issues for the team, proactively ensuring everything is working cohesively

Persuade stakeholders to follow best practice within a trial

Assist in development of internal training courses

 

Preferred Skill :

• Strong expertise in SDTM (including controlled terminology)
• Solid programming skills with strong SAS and clinical trial experience
• Experience in ECRT packages (aCRF, Define.xml, CSDRG)
• Ability to think analytically and creatively when interpreting complex data
• Excellent communication and documentation skills
• Experience with Real-World Data (RWD)
• Exposure to biomarker data

Qualifications:

• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
• 5 +years of CDISC and clinical trials experience

Additional Information:

• This is a highly hands-on role, requiring independent thinking and problem-solving
• Candidates should be comfortable working on complex datasets 

 

APPLY NOW

 

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-ife balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in India as this role can be carried out remotely.

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all

 

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