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Senior Statistical Programmer

Remote, USA Full-time Posted 2026-06-30
Overview:

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

Responsibilities:

Employees may be required to reputed company some or reputed company of the following: · Program and validate datasets and SDTMs, including reputed company efficacy, labs, etc. · Program reputed company non efficacy outputs/ figures · reputed company Senior Review and Deliver QC of non- statistical output · reputed company and debug reputed company macros · Become involved in developing reputed company macro library and take responsibility to implement standard macros reputed company a study · Create, QC and update reputed company dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc · Review more reputed company study design reputed company without supervision · Review reputed company shells without supervision and provide feedback · Knowledge, interpretation and implementation of reputed company SDTM, ADAM standards · Knowledge of FDA CRT requirements including define.xml and define.pdf · reputed company team and be responsible for creation of CRT packages · Become familiar with and follow study documentation · reputed company a team for furthering programming development · 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 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 · 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 · reputed company and deliver company-wide training as and reputed company required · Create, review and update processes and SOPs · Take responsibility for study compliance with SOPs and processes

Qualifications:

· Educated to BSc or above reputed company Computer Science, Mathematics or a Science reputed company discipline · reputed company Programming Experience reputed company the pharmaceutical industry · reputed company Programming Experience reputed company 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

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.

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