Growing within the Job
Although the data kept David interested, he did explore technical aspects of the job as well. He continued to develop his SAS programming skills by taking some database design courses at U.C. Berkeley Extension. This gave him the opportunity to work on several Oracle database projects. He also was part of the initial Rx/Clinical development team, a joint venture between Oracle and Syntex that led to Oracle Clinical, the leading clinical trial database management system used in the pharmaceutical industry.
He began to take on management responsibilities, managing both people and projects at Syntex. This continued on in his career at Chiron in Emeryville. He modestly attributed the management of people as being an easy job because the people he worked with were capable and good to work with. Since he had a good understanding of what it took to perform as a Bioanalyst, he was able to identify people who had the right balance of research and interest in the data, along with the technical programming skills. It was a combination of having the tenacity to understanding the clinical aspects of the data while having the technical skills to deliver analysis. This was what David had strived for himself and was what he looked for in forming the teams which he managed.
David is now the Associate Director of Bioanalysis at Novartis (formerly Chiron). He is very proud of the team that he put together since he started at Chiron. Davidʹs first goal at Chiron was to establish a standard set of reporting macros which would handle the standard CRF (Case Report Forms). He decided to have his Bioanalysts balance their workload of producing the day‐to‐day analysis and reporting work with developing and maintaining a standard library of macro software. The standard software mostly focused on generating safety summaries since the efficacy data usually varied too much between projects. The difference among studies didnʹt lend itself to standardization. He proceeded to assign Phil to work on Lab data, Frances to develop macros for Adverse Events, Rob to work on Demographics and Conmed while David himself worked on the Dosing information. It was a management style that allowed him to participate in the work firsthand, while motivating the team to develop software. This was all implemented on top of the normal study analysis work that they had to do. He enjoyed working on his macro component which organized dosing information into a dosing analysis file and then joined this file with time‐dependent events in a study. This allowed integrating a subjectʹs dosing experience with other study data such as adverse event and efficacy data. For example, an adverse event can occur at any specific time during the study. His macro would then merge this data with the dosing information and added variables such as the exact dose, the cumulative dose, time since last dose, etc... This was derived in association with the adverse event of this event.
Davidʹs approach to developing the macro system was to standardize any area where the potential use outweighed the development and validation costs. Having a standard macro system available provided for consistent analyses across studies, projects and output. It also prevented the programmer from having to do repetitive tasks. This allowed them to focus on the unique efficacy aspects of each study. It made the job easier and more efficient for the Bioanalyst. His team was also more engaged and interested since the work was more dynamic and became more like a unique puzzle that needs to be solved for every study.
It took a year to develop the 1st version of the software with much of the teamʹs efforts focused on the macro system without a lot of competing study analysis work. Later on, it took more time to implement subsequent version releases since the programmers usually had project work that took precedence over the standard macro development. David thinks however that this was a more cost effective approach. By giving the development efforts to the senior programmers who work with the analyses themselves, the development of software was implemented by the same individuals who understand it the most.
David has a low key approach to managing his people. He sets out goals and expects his people to work conscientiously and autonomously. He does not see himself as having a draconian style but rather a gentle coach approach. David performs peer reviews and makes suggestions but in general, leaves his people alone. He sees that it is this freedom that allows the talents of each individual to thrive and discover the unique balance of various skills to be a successful Bioanalyst.
CONSULTING SAS PROGRAMMER – GENE
Being resourceful and learning new things will keep you from becoming stagnant and become successful as a SAS programmer.
Back in the Day
Geneʹs introduction to computers and technology started back in high school in the 70ʹs when he used the Texas Instrument calculators that allowed him to program equations. He then learned assembly language and machine code on DEC PDP‐11 and Zilog Z‐80 microprocessors. Gene enjoyed working at the machine level of these 16 and 8‐bit machines because it taught