Part 2: Statistical Programming & Compliance
We sat down with the instructors for MMS Academy, MMS’ learning arm, for some advice on how to be successful to help those looking to work in the pharma industry.
In our first article, we talked with our instructors for medical writing and pharmacovigilance. This article, Part 2, features advice from our statistical programming and quality and compliance instructors.
Succeeding in Statistical Programming
Senthil Kumar, Senior Manager of Statistical Programming, has over 14 years of programming experience with complex SAS data steps and procedures and over 11 years of experience leading a program team of 10. He said a successful clinical programmer should have a blend of these attributes:
- SAS technical skills
- Understanding of clinical trials
- Basic understanding of statistics in clinical trials
- Industry standards and guidelines
- Analyst mindset (planning, execution, problem solving and decision-making skills)
- Soft skills (communication skills and basic etiquette)
- Industry collaboration (conferences, microblogging sites, etc)
Kelly Williams, Principal Statistical Programmer has extensive experience in programming and statistics and leading project teams for large submissions. Here’s what she thinks future clinical statistical programmers should know.
“If you are considering a career as a clinical statistical programmer in the industry, it would be very beneficial to have a degree in STEM. In addition, you must be CURIOUS, flexible, and seeking a career of lifelong learning. The pace is often fast and seemingly ever changing! You must enjoy and embrace this!”
Saichand Satyavarapu, Senior Manager of Statistical Programming has over 13 years of programming experience, including the creation of complex SAS data steps and procedures. Here’s his advice:
“Are you from a science background, have good computer and analytical skills? Are you highly ambitious but unsure which direction to take? Clinical Programming is the place for you!”
Succeeding in Quality & Compliance
Jennifer Perrin, Associate Director of Quality and Compliance, has over 20 years of pharma industry experience ensuring organizations achieve regulatory compliance. She has four suggestions for those looking to enter the field of quality and compliance:
- Earn a bachelor’s degree in a science field
- Seek to understand and then to be understood
- Always pay attention to the details
- Understand that Quality and Compliance are support functions
Sharon Barattini, Senior Quality and Compliance Specialist, has over 30 years of experience in quality and compliance roles. She says for those interested in a career in quality and compliance, they should:
- Read regulations and standards.
- Research the application of those regulations and standards.
- Apply what you’ve learned.
- Hone your communication skills.
- Be disciplined with good attention to detail and strong interpersonal communication skills as you will need to build professional relationships to create success in the clinical research realm.
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