Associate Director, programming permanent role (Hybrid) at California

Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines Minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry Advanced SAS programming skills Experience in other statistical software, such as R Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies Phase 3 and BLA submissions experience preferred Excellent organizational skills and ability to prioritize tasks Excellent communication and interpersonal skills Experience managing CROs and other data vendors Strong leader with a growth mindset Ability to keep pace in a fast-moving organization Advanced knowledge of state-of-art statistical programming methods in clinical study setting Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance Experience working in a remote virtual environment Ability and willingness to travel per business needs (at least 4 – 8 times per year)

Lead statistical programming activities for clinical trial projects Support building programming processes for studies and submissions Manage programmers and CROs Oversee programming activities and provide support to cross-functional teams Serve as a lead statistical programmer on clinical studies Provide statistical programming oversight to programming vendors Review and validate datasets and TFLs programmed by vendors Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, and Pharmacovigilance Develop and implement data review/reporting tools and statistical applications Participate in developing and implementing statistical programming processes and standards Review study documents and provide feedback Build and mentor a team of programmers Generate ad hoc analyses