Senior Clinical Program Analyst

Covance

Sr. Clinical Program Analyst - Sydney

At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. Covance's ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! The role of this position is to assist in the provision of a Statistical Programming service. The primary activities of the Senior Statistical Programmer are to develop and review SAS(r) programs and output for the management and reporting of clinical trial data. You will act as a Lead Programmer for increasingly complex or multi-protocol projects and to act as a Statistical Programming consultant to clients and internal customers. Duties and Responsibilities:

Act as the Lead Programmer for assigned projects.

Lead programming efforts for the preparation of electronic submissions.

Interact with project team members in related disciplines e.g. Clinical Data Management, Clinical and Biostatistics.

Assume team member responsibilities, including representing Statistical Programming at internal project team meetings, client meetings and audits.

Provide input into assessments of resource requirements on a regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.

Advise Senior Statistical Programming staff of changes in scope of projects to enable the timely development of change orders.

Provide ongoing training and mentoring within Statistical Programming to ensure thorough knowledge of the processes used and the ongoing technical development.

Assist with interviewing and selection of potential candidates.

Technical planning (which includes overseeing the set-up of the key macros/SAS programs) for multi-protocol projects (e.g., appropriate documentation required by the project).

Prepare and review of Programming Plans.

Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. data validation guidelines).

Develop and review SAS programs and output for the management of clinical trial data, the tabulation of data, preparation of patient data listings, graphical output, creation of derived datasets and statistical analysis of data as specified in the Statistical or Report Analysis Plans.

Develop SAS programs for ad hoc tables and listings. Write, modify, and maintain programs that produce diagnostics and listing for data review in support of Data Management

Carry out electronic data transfer (both incoming and outgoing). Develop and review programs to ensure the data transfer has been produced to specification.

Design and set-up utilities/SAS based systems to assist and facilitate Clinical Data Management activities.

Experience:

Approximately 3.5 years experience in provision of programming support for clinical trial management and reporting, or equivalent experience.

Extensive experience and proven skills in the use of SAS within a clinical trials environment.

Experience in the preparation and review of Programming Plans, study set-up and review of study specific documents, e.g. CRF and data validation guidelines.

Extensive experience in the development and review of SAS programs for management & reporting of clinical trial data and programs to perform electronic data transfer.

Knowledge in all aspects of clinical trials from initial study set-up to study completion.

Full knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.

Excellent problem solving skills, a proactive approach and a willingness to take decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary.

Team leadership experience, as demonstrated by ability to organize and motivate project teams.

Education:
BSc in a computing, life science, mathematical or Statistical subject or equivalent. A high computing content is considered to be beneficial, however proven computing skills are most important.

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

To apply for this exciting opportunity, please forward your CV to
Kenneth.Schneider@workplacegroup.com

Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.