Manager/Sr. Manager, Statistical Programming
Employment Type: Full-Time
Manager/Sr.Manager, Statistical ProgrammingCalithera Biosciences, Inc. is seeking a highly motivated Senior/Manager/Sr.Manager, Statistical Programmer, depending on experience, to join its Biometrics Department.BackgroundCalithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Major Responsibilities and Accountabilities* Depending on experience, the position can be up to Sr.Manager, Statisical programming.* Creates Standards, Macros, Tools, and Processes that improve the efficiency of producing analyses across molecule programs.* Oversees CRO and contractors for general programming activities including regulatory filings.* Hands on ability to produce SDTM/ADaMs as per CDISC standards and compliance, and TFLs for CSRs, adhoc reports and publications.* Experience in NDA filing, including ISS/ISE.* Experience is developing or reviewing programming functional SOPs.* Collaborates with cross-functional study teams across various of molecules/disease areas, and communicates effectively with team members.* Ability to incorporate innovative tools and methods where needed is advantageous.* Oncology experience is preferred.* Knowledge of biomarker and PK/PD data is advantageous.Qualifications* Bachelor's degree (advanced degree preferred) in programming related field (e.g. Statistics, Mathematics, Computer Science, Bioinformatics, etc.). Programming experience with SAS is required (R and other languages would be a plus).* Knowledge of clinical development and regulatory filing is required.* Efficient hands on programming ability to handle variety of projects and rapidly adapt to changing project and strategic requirements.* Ability to manage team and CRO.* Continuous learning to increase knowledge in drug development, diverse therapeutic areas, and current technology trends for analyses and visualizations.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
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