What are the responsibilities and job description for the Associate Director, Statistical Programming & Analysis position at Mirum Pharmaceuticals?
POSITION SUMMARY
Reporting directly to the Senior Director, Statistical Data Analytics & Programming, the Associate Director, Statistical Programming & Analysis will be responsible for the management and oversight of programming activities in support of multiple drug development programs. The role will be responsible for providing operational oversight of statistical programming vendors as well as performing in-house statistical programming activities in support of clinical trial analysis and reporting, regulatory filings, and data driven internal decision-making processes.
JOB FUNCTIONS/RESPONSIBILITIES
- Provide subject matter expertise and support to project teams on all statistical programming topics in alignment with project strategies.
- Perform oversight of statistical programming vendors to ensure quality and on-time delivery of statistical programming outputs.
- Develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables and figures.
- Develop and manage reusable programs to aid in efficient production of data visualizations, exploratory analyses, and statistical summaries.
- Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies.
- Contribute to overall Biometrics group in developing innovative processes to ensure high data quality and efficient reporting of analysis results.
- Take on initiative to stay current on relevant technologies, industry standards and guidelines to improve programming efficiency and facilitate review of clinical trial data.
- Ensure proper filing of study documentation consistent with regulatory compliance and conducive to inspection readiness.
QUALIFICATIONS
Education/Experience:
- At a minimum, a Master’s degree in statistics, biostatistics, data science, or a closely related field.
- 7 years of experience as a statistical programmer within the biotech/pharmaceutical industry with at least 3 years of demonstrated leadership experience and career progression.
- Experience in effectively managing statistical programming vendors and/or internal statistical programming resources for the purposes of clinical trial reporting, regulatory filings, and key internal deliverables.
- Experience in regulatory GCP inspections/audits is a plus.
Knowledge, Skills and Abilities:
- Advanced SAS programming skills in performing clinical trial data analysis and reporting.
- Strong analytical skills and demonstrated experience in gathering, interpreting, and analyzing data in clinical research and drug development.
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Excellent communication skills, ability to development rapport among cross-functional stakeholders, and passion to analyze complex issues to develop relevant and realistic programming solutions.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
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