REMOTE Principal Statistician- (Clinical)

The Principal Statistician at ClinChoice is responsible for protocol development, including study design and statistical analysis plans for assigned studies. They provide statistical oversight to ensure quality and consistency, ensure data accuracy for analyses, and mentor less experienced statisticians while managing project-related statistical activities.

To apply for the Remote Principal Statistician role at ClinChoice, candidates are expected to hold an MS or PhD in Statistics or Biostatistics. Additionally, those with a PhD should have 3-5 years of relevant experience, while those with an MS should have 7-8 years in the field, preferably in a pharmaceutical or CRO setting.

Candidates for the Principal Statistician position at ClinChoice should have experience in clinical trials within the pharmaceutical industry or CROs, including familiarity with the drug development process and interactions with regulatory agencies like the FDA. Strong oral and written communication skills are also crucial for effective collaboration.

Yes, the Principal Statistician position at ClinChoice offers the flexibility of a remote working arrangement while being part of a global team dedicated to clinical development excellence. This flexibility allows for a healthy work-life balance.

ClinChoice is committed to professional development through continuous training and guidance. The organization places significant value on nurturing its employees' skills, ensuring they are equipped to handle internal processes and client interactions effectively, while also promoting a culture of mentorship.

In my previous roles, I developed detailed statistical analysis plans tailored to the specific objectives of each study. I ensured these plans were not only technically sound but also aligned with regulatory requirements, which facilitated efficient data interpretation and communication with stakeholders.

To ensure accuracy, I implement rigorous checks at each stage of the analysis process, including validation of data entry and employing appropriate statistical methods. Additionally, I cross-reference results with earlier drafts and communicate findings clearly to avoid any misinterpretation.

I am proficient in a range of statistical methodologies including regression analysis, survival analysis, and mixed models. My goal is always to select the most appropriate method for the specific study context, optimizing results while maintaining interpretative clarity.

When discrepancies arise, I prioritize immediate investigation and rectification. I communicate with team members to track the source of the error and make necessary corrections, while documenting the process to ensure transparency and maintain the integrity of the study.

I had the opportunity to mentor a junior statistician by guiding them through a complex project. I organized regular check-ins, provided them with resources, and encouraged them to ask questions, which ultimately built their confidence and skill set in statistical methodologies.

I stay updated by regularly reading journals, attending workshops, and engaging with professional associations in the field. Additionally, I find value in attending industry conferences to learn about new software tools and methodologies that can enhance my work.

My experience with regulatory agencies such as the FDA has primarily involved preparing statistical sections for submissions and serving as a key point of contact during audits. I ensure that all statistical analyses comply with regulatory guidelines, which is vital for maintaining integrity and rigor in studies.

If results deviate from expectations, I would first conduct a thorough analysis to identify the root cause. This may involve reassessing the methodology, examining data quality, or exploring alternative hypotheses. Transparent communication with the team and stakeholders is crucial during this process.

I prioritize projects based on urgency and complexity, using project management tools to keep everything organized. I'd also communicate openly with my team about progress and potential timeline adjustments, ensuring that we deliver quality results without compromising on the deadlines.

A Principal Statistician plays a pivotal role in clinical trials by contributing to study design, data analysis, and interpretation of results. They ensure rigorous statistical practices are followed, providing insights that not only support study objectives but also promote compliance with regulatory standards.