Programming Manager

THE ROLE

Demand for our Functional Service Provision is growing, therefore we are looking for an experienced, ambitious and driven Programming Manager to join our FSP team The expectation is that the candidate has very strong CDISC knowledge with ability to line manage . We're looking for a skilled QC expert with strong experience in ADaMs and TLFs, along with solid SDTM knowledge. This role requires line management, client coordination, and proactive problem-solving.

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 and validate datasets and SDTMs, including complex efficacy, labs, etc.
• Become independent technical expert
• Program complex non efficacy outputs/ figures
• Perform Senior Review and Deliver QC of non- statistical output
• Coordinate and perform code reviews
• Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
• 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 an SDTM and ADAM expert providing consultancy, advice and training
• Be an CRT expert providing consultancy, advice and training
• Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
• Implement and coordinate the development and maintenance of PHASTAR CRT tools
• Become familiar with and follow study documentation
• Strategic Leadership for the growth of the group in line with company objectives
• Ensure the principles in the PHASTAR checklist are followed rigorously
• Develop archiving systems and processes
• 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
• 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 internal and external training; identify non-technical training needs for direct reports

. Identify areas where new processes are required and work with Operational Excellence team to implement new processes

Qualifications :

Core Competencies

• Good standard of written and verbal communication
• Facilitate project team meetings, ensure clinical trial teams are kept well informed of programming and projects at all times
• Deputise for the Head of Function at internal meetings
• Expert guidance to client
• Act as global programming lead
• Collaborate cross-functional teams to ensure expectations and objectives are aligned and being met
• Liaise with reporting teams and answer questions
• Excellent team work, with willingness to help others, ability to problem solve and seeing others point of view
• Enthusiastic and positive outlook
• Calm and professional under all circumstances
• Accept new challenges as learning opportunities
• Implement approaches that will result in error-free results
• Flexible and adaptable in outlook
• Open to feedback with a view of continual improvement
• Ability to adjust priorities where necessary
• Ability to make timely decisions relating to technical project issues
• Strong attention to detail
• Understanding of regulatory requirements
• Working in a proactive manner to identify and rectify study issues
• Working with complete autonomy

Other Required Skills and Abilities

• Proactively identify own areas of development/improvement
• Sharing knowledge through attending and presenting at the programming forums and external conferences
• Helping to network for potential recruits as and when required
• Be involved in bid defence and other sales meetings helping to estimate resources required
• Bring industry changes to the attention of the company and be involved in updating processes
• Ability to drive efficiency to optimise outcome
• Train and mentor less experienced team members
• Line manage senior team members ensuring that each individual has the opportunity to reach their potential and identify their areas of development
• Coach and encourage internal and external teams about best practices which bring additional value
• Critical review of any publications
• Lead a team to create publications
• Representing the company at external events

Experience and Education Requirements

• 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

APPLY NOW

With the worlds 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!

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.

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