Sr. Statistical Programmer/Manager Statistical Programming

Calithera Biosciences, Inc. South San Francisco , CA 94080

Posted 2 months ago

Sr. Statistical Programmer/Manager, Statistical Programming

Calithera Biosciences, Inc. is seeking a highly motivated Senior Statistical Programmer/Manager, Statistical Programming, to join its Biometrics Department.


Calithera 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:

  • Ability to build and lead the programming team for the company.

  • Depending on experience, the position can be the head of the statistical programming group.

  • Creates standards, 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 statistical outputs and reports for clinical trials and publications.

  • Have good understanding of FDA/health authority submission process.

  • 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.

  • Knowledge of biomarker and PK/PD data is advantageous.


  • 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. Oncology experience is preferred.

  • 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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Statistical Programmer

Seattle Genetics

Posted 1 week ago

VIEW JOBS 10/9/2019 12:00:00 AM 2020-01-07T00:00 Summary: Seattle Genetics is seeking a Principal Statistical Programmer to join our rapidly growing Biometrics team. You are the ideal candidate for this position if you can drive for results and communicate effectively in a highly collaborative and dynamic environment. In this role, you will design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans. In a leadership role on a study or integration, you will interact with cross functional study teams at a high level to proactively determine programming tasks, timelines, assignments, and resource requirements and oversee study or integration programming efforts to ensure the timely delivery of high-quality outputs according to company and industry standards. You will contribute expertise in the review of case report forms, data management plans, and data set or reporting specifications. As a detail-oriented team member, you will recognize inconsistencies and initiate resolution of data problems when necessary. You may also assist programming management with or be the lead on cross-functional process improvement initiatives and resource allocation. Responsibilities: * Develop and validate SAS® programs to produce high quality data sets, tables, figures, and listings within set timelines in accordance with company and regulatory requirements * Independently implement complex analysis algorithms for assigned projects or studies * Provide statistical programming support for several studies and integrations on a product * Ensure compliance with company and industry standards, and contribute to specifications for assigned products based on analysis need and ensure compliance with company and industry standards * Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans, table, listing, and figure shells, data management plans, data transfer plans, and case report forms * Communicate clearly and proactively with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities * Initiate, lead, and participate in planned departmental and cross functional initiatives that facilitate standards, infrastructure, and process enhancements * Assist programming management on resource allocation * Train and mentor new and junior programmers Requirements: * BS and 8+ years of software development and/or programming experience in the biotech, pharmaceutical, medical device, and healthcare industries; MS/PhD and 6+ years of software development and/or programming experience in these industries * 5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings and figures for Phase I-IV clinical studies * 3+ years of experience in overseeing statistical programming projects * 3+ years of experience in writing SAS macros * Expert knowledge and understanding of SAS® programming concepts and skills * Demonstrated proactivity and strong attention to detail * Experience in oncology studies; experience with integrations and electronic submissions preferred * Good understanding of and hands-on experience with CDISC, SDTM, and ADaM standards; understanding of electronic submission requirements and guidance preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-TC1 Seattle Genetics South San Francisco CA

Sr. Statistical Programmer/Manager Statistical Programming

Calithera Biosciences, Inc.