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Senior / Principal Programmer-Data anonymization

PHASTAR
Remote

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Job details

Permanent | Full-time

Qualifications

Computer Science
XML
SAS
B.Sc
SAP
Bachelor's degree
Macros
Clinical trials
Debugging
FDA regulations

Full job description

Overview:

Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.

Responsibilities:

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

Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
Program complex non efficacy outputs/ figures
Perform Senior Review and Deliver QC of non- statistical output
Develop and debug complex macros
Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
Review more complex study design SAP without supervision
Review all shells without supervision and provide feedback
Knowledge, interpretation and implementation of current SDTM, ADAM standards
Knowledge of FDA CRT requirements including define.xml and define.pdf
Lead team and be responsible for creation of CRT packages
Become familiar with and follow study documentation
Lead a team for furthering programming development
Ensure the principles in the PHASTAR checklist are followed rigorously
Archive study documentation following instructions in supplied SOPs
Act as a Lead programmer on multiple studies under same project, ensuring quality and timely delivery
Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
Responsible for study level resources
Attend and input to company resourcing meeting
Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
Persuade stakeholders to follow best practice within a trial
Develop and deliver company-wide training as and when required
Create, review and update processes and SOPs
Take responsibility for study compliance with SOPs and processes

Technical Skills:

Experience with CDISC Standards (SDTM, ADaM) and regulatory submissions.

Understand Clinical trial data very well.

Strong understanding of clinical trial data flow, from raw datasets to submission-ready formats.

Experience with multiple therapeutic areas

Strong production hands-on TFL programming skills for in-house projects.

Preferred Skills:

Data anonymization

Disclosure data.

Qualifications:

Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
SAS Programming Experience within the pharmaceutical industry
SAS Programming Experience within the pharmaceutical industry
Good awareness of clinical trial issues, design, and implementation.
Familiarity with GCP and regulatory requirements
Experience of programming to SDTM and ADaM standards

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.

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