Webinar highlights: Dual roles: I am not just a programmer

The most satisfied and hard-working employees are those who feel challenged and supported in their professional development. Employees at CROS NT can work in dual roles, not only in management but also in operational areas. This gives experienced employees the opportunity to move into roles with more leadership potential or which demand higher-level or different technical skills.

On March 31, CROS NT hosted a complimentary webinar on the ways statistical programmers can work in dual roles and expand their skill set, as well as support different operational groups and get involved in the upfront project planning. The webinar was based on a paper titled “Dual Roles: I’m not just a programmer!” created by Laura Williams, CROS NT Senior Statistical Programmer and Biostatistician, and Hunter Vega, CROS NT Principal Statistical Programmer and Project Manager, for the PhUSE US Connect 2020 conference.

Continue reading for key highlights from the webinar.

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How statistical programmers can work in dual roles

Vital experience can be gained by working in other operational departments, this interaction can inspire statistical programmers who are interested in a broader career path. In addition, statistical programmers may have experience which is relevant in other departments. Below are observations from two of our statistical programmers who have embraced working in dual roles, describing the relevance of their skills in different areas of the business.

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Figure 1: Dual Roles for Statistical Programmers at CROS NT

Programmer to Biostatistician

At CROS NT, entry-level technical employees, with an education in statistics, often start as statistical programmers. Although many continue working as programmers, some move to roles in biostatistics. By working in a dual role, the programmer can gain experience and develop new skills, as well as benefit the company by taking on workload in both departments. In addition, certain technical knowledge and responsibilities, such as coding statistical models or filing study documentation for a statistical analysis, is often shared between the lead programmer and study biostatistician.

The study biostatistician works closely with the lead statistical programmer to perform the planned statistical analysis for a clinical study. Both parties must understand the goals of the study, to ensure the analysis is aligned with the protocol. The client may not have the expertise to plan the statistical analysis or ensure the data standards for regulatory submission are met. Both the lead programmer and biostatistician can provide the technical support needed, giving insight into what type of analysis is feasible based on the study design and data collection processes. The programmer and biostatistician should also be familiar with the regulatory requirements for submission of the data and statistical analysis and be able to play an active part in the submission process. In our experience, a statistical programming background can give unique insights into other aspects of operations, such as creating specifications for outputs or providing feedback on CDISC standards to a study sponsor.

Dual Roles: I am not just a programmer! Figure 2: Clinical Study Process for Biometrics Projects

Programmer to Project Manager

Statistical programmers with experience leading studies, supporting business development, and mentoring staff may be interested in project management. The organizational skills gained from managing the programming team can be applied to managing all aspects of a biometrics project, from designing the CRF to finalization of the study report. A project manager is often the main point of contact with the client, this means that statistical programmers moving towards a project management role will need to develop their skills so that they can communicate effectively with all members of the study team.

The lead programmer is responsible for ensuring the programming deliverables are completed on time. Project managers are responsible for delivering all components of a project in a timely manner and must be aware of how delays to one process can impact on other project deliverables. For example, if the database lock is delayed, the statistical analysis timelines will need to be adjusted accordingly. The project manager also needs to be aware that changing timelines can impact on the availability of resources, such as biostatisticians and statistical programmers, thus resources may need to be re-allocated or outsourced.

The lead programmer is also responsible for managing the programming team to ensure adherence to budgeted hours, by monitoring time logged during the project and following up with team members who may be struggling to complete tasks on time. Similarly, the project manager has responsibility to ensure that all team members, not just statistical programmers, complete their tasks within budget. If a task proves larger in scope or more complex than originally planned, then the project manager is responsible for updating the contract to take this into account. However, if the project team is struggling to complete tasks on time, even though the scope and complexity are as expected, the project manager must work with the functional leads and implement actions to improve efficiency and keep tasks within budget.

The value of dual roles

Senior-level statistical programmers may feel that there is a lack of opportunity to take on larger responsibilities within the business. However, those who feel ready to take the next career step are encouraged to evaluate their skillset, as it may be relevant for a new or different role. With this knowledge, alternative career options, such as a dual role position, can be explored. Dual roles provide the unique opportunity to foster a cross-disciplinary experience, improve communication and leadership skills, and bring valuable insights to project teams.

This article is based on a Webinar presented by Laura Williams on 31st March 2020. Register today to get access to the webinar recording.

About Laura Williams, Senior Statistical Programmer and Biostatistician of CROS NT

Laura has worked in public health and clinical research for 9 years and joined CROS NT as a Statistical Programmer in 2015. Her areas of expertise cover multiple aspects of SAS programming applied to clinical research and data analysis.

Her main responsibilities include SDTM/ADaM conversions, TLF programming and validation, as well as creation of the CDISC associated documentation. Laura is a very talented graph programmer and regularly trains and mentors her colleagues. She has successfully led multiple projects as a lead programmer and has coordinated large scale projects to successful completion.

Laura holds a Master’s degree in Applied Statistics from Pennsylvania State University and joined the Biostatistics team at CROS NT in 2019.

Learn more about Laura Williams, her career path and current role in CROS NT in our “Career Insights” section

About Hunter Vega, Principal Statistical Programmer and Project Manager of CROS NT

Hunter has worked in clinical research for 12 years. She joined CROS NT in 2008 as a statistical programmer where she has gained experience in all phases of drug development and medical device trials.
As a biometrics project manager, in our team she has primary responsibility for the planning and oversight of multiple projects from initiation to closure, including all data and reporting activities. Her therapeutic experience includes oncology, audiology, cardiology, dermatology, dental, diagnostics, gastroenterology, immunology, neurology, and orthopaedics. Hunter is also a principal level statistical programming lead with vast experience in leading projects and teams to successful deliveries.