Associate Director, Programming

at  Phastar

THE COMPANY

Phastar is a multiple award-winning 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.

We are seeking an Associate Director, Programming to be responsible for the programming activities and line management of programmers within the company. Guiding programmers in their work, performing senior review of documentations and output deliveries, providing oversight and advising on best practices approach to clinical trials. Working hands-on across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines, producing, reviewing and updating complex dataset specifications (including efficacy). Input to quality processes; process improvements within the programming function; reviewing SOPs; involvement in CAPA processes and ensuring implementation of quality processes.
This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.
Responsibilities:

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

• To assist the Director, Programming and act as their delegate, as necessary
• Help the Director, Programming identify areas of skill development needs and improvements for the programming function
• Provide leadership of members of the programming group within specified geographical regions
• Line manage senior members of staff within the programming function, ensuring individuals are managed to allow individuals to have the opportunity to reach their full potential
• Support company strategic initiatives/decisions to contribute towards the growth of the group in line with company objectives
• Assist with the recruitment, interviews, and training of new employees within the programming function, as needed
• Program and validate analysis datasets and SDTMs, including complex efficacy, labs, etc.
• Become independent technical expert
• Perform Senior Review and Deliver QC of non- statistical output
• Coordinate and perform code reviews
• Become involved in developing and maintaining the standard macro library
• Validate and perform User Acceptance Testing (UAT) on standard macros
• Identify macros requirements, communicate and perform training
• Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.
• Implement and coordinate development and maintenance of PHASTAR standard specifications
• Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
• Become familiar with and follow study documentation
• Contribute to the development, implementation and adherence to best practices and the Phastar checklist
• Ensure the principles in the PHASTAR checklist are followed rigorously
• Ensure documentation for direct reports is audit ready at all times
• Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery
• Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
• Responsible for study level resources and resolving resourcing issues with direct reports
• Persuade stakeholders to follow best practice within a trial
• Develop and deliver internal and external training; identify non-technical training needs for direct reports
• Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
• Training and mentoring line managers within the Programming function
• Resolve any obstacles for programming team members
• Support the review of programming related SOPs and ensure processes and practices reflect reporting requirements
• Involvement in the CAPA process
• Identify new procedures and processes for improvement and efficiency
• Motivate and inspire others
• Maintain visibility to external customers (e.g. white papers, blogs, LinkedIn posts etc.)
• Maintain a positive client relationship

Qualifications:
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- Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
- SAS Programming Experience within the pharmaceutical industry
- Good awareness of clinical trial issues, design, and implementation
- Experience of regulatory submissions and associated industry guidance
- Familiarity with GCP and regulatory requirements
- Knowledge of SDTM and ADaM CDISC standardsAPPLY 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-life 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 the UK 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.