Sr. Manager/Associate Director/Director, Statistics & Statistical Programming

Job Summary

The Senior Manager / Associate Director / Director, Statistics and Statistical Programming, will be responsible for various analysis, programming and validation activities to support clinical trials from early-stage through regulatory submission. They will work closely with Biostatistics, Clinical Data Management, Clinical Operations, and external CRO partners to ensure high-quality, compliant deliverables that support study reporting and regulatory submissions. This will be a hybrid programmer / statistician position, with ability to specialize in either as the department grows.

Job Location

This role can be hybrid out of the San Diego office or fully remote; preference for a candidate based on the West Coast of the United States with some travel to the San Diego office. Visa support is NOT available for this position.

Requirements

• Graduate degree required in Statistics, Biostatistics or closely related fields
• Minimum of 3-5 years of experience in pharmaceutical/biotech with experience programming in a clinical trial environment to support regulatory submissions
• Expert level of SAS programming skills; knowledge of some additional programming languages (e.g. R, Python, Spotfire) a plus
• Expert knowledge regarding clinical trial design, data collection/cleaning, regulatory requirements and their relationship with data analysis
• Familiar with ICH guidelines, possess advanced knowledge of submission requirements and standards
• Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM, and ability to oversee vendors creating CDISC outputs
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests; ability to investigate data and add value through exploratory analyses with minimal prompting
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
• Strong organizational and multitasking skills
• Excellent communication and interpersonal skills

Benefits

• Competitive total compensation package
• Work in a supportive team environment
• A competitive salary range for candidates who will work in San Diego, CA, is $155,000 - $230,000 annually
• 90% employer-covered benefits
• A flexible PTO
• A very generous holiday schedule that includes a week off in August and time off around the winter holidays
• A well-stocked kitchen with snacks and beverages
• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match
• A comprehensive wellness program includes medical, dental, vision, and LTD coverage