Director, Statistical Programming (Office OR Remote)

Description

The Director, Statistical Programming will provide leadership to the team for the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming. This position will report into the Head of Statistical Programming 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 position requires high degree of independence, technical skills, and ability to influence the team to get results with or without line management authority.

This is a unique opportunity to join a 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.

Job Duties And Responsibilities

• Lead on develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review
• Adopts strategic approach to producing and prioritizing analytical deliverables, incorporating innovative tools and methods where needed.
• Generate or validate ADaM datasets and TFLs, reviewer’s guide, and define files.
• Manage on-time and quality delivery for both in-house and outsourced projects.
• Work with data management to review case report forms, database specifications, and data transfer specifications
• Demonstrated excellent experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements
• Performs stakeholder management, negotiating timelines and scope of deliverables (helping to balance team and company needs with speed, rigor and clarity of message)
• Provides leadership or project management to major data-heavy study or project team deliverables or initiatives
• Lead and/or participate in standards governance and developing biometric department operational processes.
• Lead statistical programming standards development and process improvements activities.
• Increased responsibility of implementing programming standards and TMF archival of statistical programs and datasets.
• May manage/mentor statistical programming staff if 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 12 years of biotechnology or pharmaceutical experience with oncology experience.
• Good experience on working in a leadership position and team management. Demonstrated strategic capabilities, ability to see and understand broader, enterprise level perspective.
• Excellent Programming experience in SAS is a must. Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred.
• Experience managing delivery of statistical programming projects by CROs and in-house Statistical Programming team.
• Experience of leading initiatives within Statistical Programming and/or Biometrics team
• In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, real-world, etc.).
• Familiar with the expectations of regulatory agencies. Hands-on experience with NDA/BLA or other regulatory filing activities.
• Demonstrated ability to rapidly adapt to changing projects and strategic requirements
• Interest in continuing education, particularly in the areas of business knowledge as well as technology trends for producing analyses and visualizations (particularly with an eye towards reproducibility or interactivity)
• Takes a fit-for-purpose mindset to daily work as well as long-term vision
  
  

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 $225,000 - $250,000 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.

EOE

Arcus 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

Physical Requirements Office Setting

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.