Stats Programming Team Manager - Sydney, Australia - Avance Clinical

Avance Clinical

Verified Company

Sydney, Australia

1 week ago

Posted by:

Olivia Brown

beBee Recruiter

Description

Remote or office based positions

Global CRO
Reputable organization with growth opportunities

Avance Clinical is a Contract Research Organisation which offers specialised services supporting clinical drug development for the pharmaceutical and biotechnology industry.

The Statistical Programming Team Manager is responsible for the oversight of statistical programming operations (including SAS programming and CDISC programming) and team, and for reporting to Senior Management.

Why should you join Avance Clinical?
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

Core Responsibilities

Ensure a high level of client service is delivered and maintained in terms of product and timelines, whilst also delivering projects within budget.
Provide a strong, cohesive link between the Statistical Programming (i.e. SAS programming and CDISC programming) Team and Biometrics (i.e. Statistics and Pharmacokinetics) and Data Teams and the Head Biostatistics ensuring clear and defined communication pathways are established.
Report regularly to the Head Biostatistics in respect to Statistical Programming (i.e. SAS programming and CDISC programming) group operations, resourcing, system issues, project performance and potential project slippages.
Provide considered justification statements to the Head Biostatistics relative to resource expenditure.
Monitor projects against milestones and budget.
Provide leadership in issue resolution with external parties, i.e. clients and external auditors.
Identification and remediation of issues arising that may affect the planned completion of client projects including provision of support, guidance and assistance (when necessary) to Statistical Programming staff to meet project milestones.
Facilitate communication between all project stakeholders and ensure that regular updates are provided in accordance with each study plan.
Participate in client meetings and Audits as required.

Qualifications, Skills and Experience

Ordinary degree in the appropriate discipline or appropriate industry experience.
Minimum 7 years' experience in the pharmaceutical industry / Clinical Research Organisation (CRO) working in a GCP environment.
Minimum of 7 years statistical programming experience.
Demonstrated leadership and mentoring skills.
Ability to communicate at a high level with clients, senior management and other stakeholders.
Excellent oral and written communication skills including the ability to prepare reports and SOPs.
Intermediate to advanced MS Office Suite.
Excellent time management and organisational skills with the drive to be outcome focussed.
Demonstrated ability to prioritise work and handle deadline pressure in a multidisciplinary team environment.
Knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes _(highly desirable)_.
Commercial links with pharmaceutical and biotechnology industry _(highly desirable)._

What we offer