Senior Statistical Programmer, Early Stage Development and PK/PD Modeling and Simulation Consultant (Hybrid at PA/NJ)

As a Senior Statistical Programmer at ClinChoice, you will undertake a range of responsibilities aimed at providing high-quality statistical programming deliverables for global stakeholders, particularly in Early Development Statistics and PK/PD Modeling and Simulation. Your role will involve gathering user requirements for programming requests, transforming data into modeling datasets, and developing detailed tables, listings, and figures based on statistical analysis plans. You'll also be crucial in preparing compliant programming code for regulatory submissions and supporting the development of programming standards for efficient production.

To qualify for the Senior Statistical Programmer position at ClinChoice, candidates should possess either a BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related fields along with at least 5 years of SAS programming experience in a clinical trial context; or an MS in a related field with a minimum of 3 years of relevant experience. An effective understanding of clinical endpoint data and pharmacokinetic data is essential, as well as experience with CDISC SDTM and ADaM standards.

Success as a Senior Statistical Programmer at ClinChoice hinges on strong programming expertise in SAS, particularly with data steps, procedures, SAS/MACRO, and SAS/GRAPH. Excellent communication skills are also critical as you will be collaborating with various stakeholders. Additionally, familiarity with clinical pharmacology concepts, the ability to comprehend complex analysis plans, and experience with other software such as R or Splus, will enhance your effectiveness in this role.

ClinChoice is committed to the continuous training and development of its employees, including Senior Statistical Programmers. The company emphasizes building a culture of knowledge-sharing and skill enhancement. You will have access to various training programs and resources needed to maintain high expertise, which is vital for managing both internal and client processes effectively. This focus on professional growth contributes to career advancement opportunities within the organization.

At ClinChoice, the core value is to contribute positively to a healthier and safer world through innovative drug development. The company values diversity and inclusivity, recognizing that employees from varied backgrounds strengthen the organization. A supportive culture, dedicated to professional development and employee well-being, creates a dynamic work environment where your contributions are celebrated.

When answering this question, focus on specific projects where you've utilized SAS programming. Discuss the types of data you worked with, the programming techniques you implemented, and how your efforts contributed to the success of the trials. Emphasize any experience you have with generating tables and listings for regulatory submissions to showcase your relative expertise.

To demonstrate your commitment to data integrity, talk about methods you use to maintain accuracy during the programming process, such as validating data inputs, performing checks on outputs, and establishing programmatic traceability from raw data to results. Providing examples of any challenges you faced in maintaining integrity and how you resolved those issues can further strengthen your response.

Answer by discussing industry standards such as CDISC SDTM and ADaM, and how you implement them in your programming. You can also mention any internal standards your previous employers had and how adherence to these standards improved the quality and consistency of statistical outputs in your projects.

For this question, choose a specific statistical method that you've used in a recent project and explain it in simple terms. Highlight your understanding of the method's objectives, how it was programmed, the rationale behind its use, and the impact it had on the overall analysis. This will showcase your analytical skills and depth of knowledge.

Discuss your open-mindedness towards feedback and any specific situations where constructive criticism led to improvements in your work. Emphasize your desire to learn and grow from feedback, as well as your collaboration with colleagues in refining your programming outputs.

Reflect on occasions where you've collaborated with different professionals, such as biostatisticians, data managers, and project leads. Focus on communication strategies you employed to bridge any gaps and ensure smooth teamwork. Highlight how these interactions contributed to the project's success, supporting the idea that teamwork is essential in a CRO environment.

When responding, list any relevant programming languages or software that you've worked with, such as R, NonMem, or Splus. Be prepared to give examples of how you used these tools in past projects and how they complemented your SAS skills, elucidating your versatility as a programmer.

Explain your approach to task management, which might involve creating to-do lists, setting deadlines, and utilizing project management tools. Speak about how you adapt your priority list based on project urgency and importance, ensuring that you meet deadlines without compromising on quality.

Choose a specific project or outcome that had a significant impact on your career. Describe the challenges you faced, how you overcame them, and the results you achieved. This will illustrate your skills and dedication while also showcasing your commitment to high-quality work.

Express your admiration for ClinChoice’s mission and values, emphasizing their dedication to quality, employee development, and inclusivity. Tie your aspirations and experiences into the ethos of the company, highlighting how your goals align with theirs and why you believe you would be a great fit for the team.