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OBJECTIVES
- Manage assigned projects and line manage assigned personnel.
- Provide technical input and leadership in the preparation and review of high
quality programming deliverables and documentation, as well as the processes and
standards required, to both colleagues and clients.
- Provide high‑quality, timely programming support that conforms to current
Quanticate (or client-specific) standard operating procedures (SOPs) and
processes, as well as applicable regulatory requirements and/or guidelines on
behalf of the client.
PROCEDURES
- May be directly responsible for the line management of up to 6 Programmers.
- Perform an active role in the development for direct reports and/or provide
consulting, training, mentorship and support for programmers as necessary.
- Approve the timesheets of direct reports and review the timesheet entries
which impact functional Key Performance Indicators.
- Supervision of direct reports through fortnightly or monthly meetings as a
minimum and provision of day-to-day support on an informal ongoing basis, as
required.
- Perform annual and interim reviews in accordance with HR processes and SOPs
for direct reports.
- May provide leadership on the preparation and review of programming
deliverables and outputs for use in clinical study reports, regulatory
submissions (ICH‑compliant) and publications, as well as the processes and
standards required, to both colleagues and clients.
- May project manage projects to provide high quality deliverables, excellent
customer care and appropriate communication to the client within expected
timelines and budget.
- Pro-actively address changing timelines, priorities and resourcing
requirements
in line with any issue escalation processes.
- Provide support within the function on programming standards, processes, and
procedures, as well as to other Quanticate functions and externally to clients.
- Assist Principal Programmers with recruitment activities and assess potential
new recruits by evaluating technical skills tests and interviewing candidates.
Maintain up-to-date knowledge of the external regulatory environment relating to
programming, including ICH/GCP requirements, and provide advice and educate
colleagues (and clients) on changes to regulatory requirements and/or other
guidelines relating to programming.
Key Contacts/Relationships (Internal and External)
Internal
- Has a close working relationship with the Principal Programmers and other
functional staff. On a project level, a Senior Programmer organises the quality
control of deliverables and ensure quality control documents are completed by
other Senior Programmers and Programmers.
- May deputise for a Principal Programmer, liaising with other Principal
Programmers, other functions and the Head of SRBU Programming, as
appropriate.
- Works closely with the project study teams (statisticians, clinicians, medical
writers, project management) for the successful delivery of programming
activities.
External
- Interacts extensively with the client (including client PoC, Clinician,
Statistician,
Study Manager, Clinical Protocol Manager) to complete various programming
activities. To fulfil this role, the Senior Programmer may be required to be a
key
participant in project team meetings and be responsive on an ad hoc basis, as
required.
PERSON SPECIFICATION
Education:
- Qualified to BSc, BA or equivalent , preferably in a numerate discipliner />
AnAnd / or
- Relevant past experience within the pharmaceutical industry or medical r />
Work Experience:
- Preferably have at least 4 years’ experience as a programmer within the
pharmaceutical industry.
- Knowledge and experience on pharmaceutical industry and requirements for r />
delivery of clinical trials.
SkSkills
- Should have PC skills, good knowledge of statistical software packages r />
sector or an understanding of basic statistics.
(particularly SAS), good organisational skills, good communication skills
(oral and written), good analytical skills, and a continuous improvement
mentality and attention to detail.
