Associate Director - Statistical Programming

April 10

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Neumora

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Neumora is redefining the field of neuroscience drug development by pioneering a new era of precision medicines for brain diseases. With a focus on developing targeted and effective therapies, Neumora aims to address the global brain disease crisis that affects over 1. 5 billion people. Their innovative approach revolves around the development of therapeutically relevant targets in Central Nervous System (CNS) diseases, emphasizing novel mechanisms of action and best-in-class pharmacology. The company's efforts are supported by their Precision Toolbox, which integrates translational, clinical, and computational tools to advance precision medicine approaches. Neumora is committed to transforming the future treatment of brain diseases by assembling a team of dedicated neuroscience drug developers and data scientists.

51 - 200 employees

Founded 2021

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. • The Associate Director, Statistical Programming provides support to compounds from clinical development to regulatory filing to commercialization. • Reporting to the Director, Statistical Programming, they work closely with Biostatisticians and Clinical Data Management colleagues to support Biometrics team deliverables. • Holds the primary responsibilities of ensuring the accuracy of post-EDC datasets (SDTM and ADaM) creation from reviewing specifications to performing independent quality control validation using own SAS programs. • Ensures clinical trial data collection and post-EDC datasets are consistent with industry standards and ready for eDATA submission. • Works closely with biostatisticians using own SAS programs to perform statistical data analysis to support internal decision making, regulatory communication, or drug product commercialization. • Performs independent quality control validation for analytic outputs delivered by statistical vendors or by colleagues in Neumora’s Biometrics team. • Works closely with Clinical Data Management colleagues to produce systematical data reports to support effective clinical trial data review and cleaning. • Works directly with study team members in Clinical Development and Clinical Operations to provide programming to address data-related questions and to support identification of protocol deviations. • Manages study-level programming deliverable timeline in collaboration with study lead biostatistician. • Manages statistical computing environment from folder structure to access control. • Follows good programming practices and internal program validation process. • Provides mentorship and support to junior level statistical programmers.

🎯 Requirements

• B.A. / B.S. with at least 15 years of experience or an M.S. with at least 10 years of experience in using statistical programming to support clinical trials in pharmaceutical/biotech or CRO setting • Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro language, and commonly used procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED) • Rich experience in following pharmaceutical data standards to create post-EDC datasets (STDM and ADaM) and to create DEFINE packages for eDATA submission to support regulatory filing • Strong organizational skills and time management skills • Detail-oriented and holds high standards of excellence for work product • Effective in delivering in the work-from-home environment • Excellent interpersonal skills, an effective communicator, and a good team player • Experience with Python to integrate study-specific details with existing files to assist with periodic data review is a plus • Experience managing junior statistical programmers to deliver is a plus

🏖️ Benefits

• Medical, dental, vision, and life insurance • 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution) • Company Equity (New Hire Awards, Annual Awards, ESPP) • Annual paid time off: • Accrued Vacation Days: 15 days per year • Sick Days: 10 days per year • Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December • Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability • Discretionary year-end bonus