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
Important notice to Employment businesses/Agencies
Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. 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 Phastar. Phastar 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.
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
Important notice to Employment businesses/Agencies
Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. 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 Phastar. Phastar 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.