Principal Clinical Programmer (Office OR Remote)

The Principal Clinical Programmer will be responsible for support of team data review, data reconciliation and edit checks, and programming submission ready SDTM deliverables. This position will report to a Director of Clinical Programming or higher and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.

This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work.  Responsibilities:

• Working from specifications developed by Data Management, independently build and execute programs for internal data reviews, data reconciliation, and edit checks.
• Lead in the development and maintenance of clinical programming related standards and tools.
• Work with data management to review case report forms, database specifications and similar documents.
• Independently develop data transfer specifications and manage the transfer of external data.
• Program SDTM datasets and produce related CDISC deliverables such as aCRF, define.xml, reviewer’s guide, etc.
• Performs stakeholder management, negotiating timelines and scope of deliverables.
• Participate in standards governance and developing biometric department operational processes.
• Mentor Clinical Programming staff as needed.

Qualifications:

• Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
• Minimum 6+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred.
• Advanced programming experience in SAS. Experience working with other languages (R) in validated environments is a plus.
• Solid, demonstrated experience with CDISC data standards (CDASH, SDTM).
• In-depth knowledge of data standards and demonstrated experience in the handling of non-CRF data including proven ability to work with diverse data types, such as biomarker, PK/PD, pharmacovigilance, etc.
• Demonstrated ability to rapidly adapt to changing project and strategic requirements.
• Takes a fit-for-purpose mindset to daily work as well as long-term vision.

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.  This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $185,000 - $195,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.  EOEArcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets  #LI-EW1#LI-Remote Apply