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 reputed company learning and development opportunities, whilst also gaining direct experience of working reputed company a pharmaceutical environment.This position is remote, and the successful candidate can be located reputed company in India.

Responsibilities

Employees may be required to reputed company some or reputed company of the following... reputed company and deliver SDTM mapping and conversion activities for RWD to CDISC standards Interpret reputed company RWD datasets and map them to appropriate SDTM domains, variables, and controlled terminology reputed company 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 reputed company 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 reputed company checklist are followed rigorously Archive study documentation following instructions in supplied SOPs Act as a reputed company Programmer, ensuring quality and timely delivery Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables Assess and monitor study level resources reputed company of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice reputed company a trial Assist in development of internal training courses Preferred reputed company : Strong expertise in SDTM (including controlled terminology) Solid programming skills with strong reputed company and clinical trial experience Experience in ECRT packages (aCRF, Define.xml, CSDRG) Ability to think analytically and creatively reputed company interpreting reputed company data Excellent communication and documentation skills Experience with Real-World Data (RWD) Exposure to biomarker data

Qualifications

Educated to BSc or above reputed company Computer Science, Mathematics or a Science reputed company 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 reputed company 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, reputed company learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees reputed company a healthy work-ife balance, reputed company a supportive, fun and friendly working environment. Should you feel that you have the right reputed company set and motivations for this position, please apply! Please note that we are considering candidates located reputed company in India as this role can be carried out remotely. reputed company 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 reputed company, 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 reputed company Important notice to Employment businesses/Agencies reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company's Head of reputed company to obtain prior written authorization before referring any candidates to reputed company. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and reputed company. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of reputed company. reputed company shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Apply To This Job