Senior Principal Statistical Programmer - Submissions
Senior Principal Statistical Programmer - Submissions
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Job Description
Job Title: Senior/ Principal Statistical Programmer Submissions
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
THE COMPANY
Phastar is a multiple awardwinning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time quality biostatistics programming data management and data science services. With offices across the UK US Germany Denmark Kenya Australia India China and Japan Phastar is the second largest specialized biometrics provider globally and the largest in the UK.
Our unique approach to data analysis “The Phastar Discipline” has led us to build a reputation for outstanding quality. With this as our core focus we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.
WHY PHASTAR
Accredited as an outstanding company to work for Phastar is committed to employee engagement workplace satisfaction and ensuring a healthy worklife balance. We offer flexible working parttime hours involvement in developing companywide initiatives structured training and development plans and a truly supportive fun and friendly environment.
What’s more when you join our team Phastar will plant a tree in your honour as one of our Environmental Social and Governance (ESG) initiatives. So not only would you get your dream job you’ll also be helping to save the planet!
THE ROLE
Demand for our Functional Service Provision is growing therefore we are looking for an experienced ambitious and driven Programmer to join our Center of Excellence and submissions team. The expectation is that the candidate has very strong CDISC knowledge.
As Senior/Principal Programmer you will be fully integrated into our sponsor’s submission excellence team as a key contributor providing handson technical eSUB expertise including guidance define reviewer’s guide for submission of clinical trial data for FDA PMDA and EMA regulatory agencies.
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.
Responsibilities
Employees may be required to perform some or all of the following:
- 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 companywide training as and when required
- Create review and update processes and SOPs
- Take responsibility for study compliance with SOPs and processes
Qualifications
- Educated to BSc or above within Computer Science Mathematics or a Science related discipline
- SAS Programming Experience within the pharmaceutical industry
- Experience with ISS and ISE
- Good awareness of clinical trial issues design and implementation.· Familiarity with GCP and regulatory requirements
- Experience of programming to SDTM and ADaM standards
APPLY NOW
With the world’s eyes focused on clinical trial data this is a fantastic time to join an awardwinning specialized biometric CRO that is renowned for its technical expertise outstanding quality and cuttingedge data science techniques. We offer flexible working parttime 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 worklife 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!
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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Employment Type
Full Time
