SUMMARY/JOB PURPOSE: Manages a statistical programming team to develop, validate, and ensure the quality of statistical and clinical SAS programs to support oncology drug development. Statistical programs include those to generate datasets, tables, listings, and figures for clinical study reports, integrated summaries, periodic safety and regulatory reporting, investigator brochures, core value dossiers, responses to regulatory questions, presentations, and publications. ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for oversight of all aspects of a SAS programming team
- Sets employee goals, conducts performance assessments and mentors and provides professional development opportunities for staff.
- As part of the Statistical Programming leadership team, defines, develops, and implements procedures, guidelines, and policies for good programming practices.
- Adheres to FDA regulations regarding training records, guidelines, and SOPs.
- Remains current on emerging regulations, requirements, and guidance that relate to FDA data submission standards; develops strategic plans for implementation and adherence
- Seeks continual improvement: creates or modifies processes to improve effectiveness, efficiency, communication, or compliance.
- Works on multiple tasks simultaneously and prioritizes tasks to meet timelines regularly.
- Defines training curriculum for new employees and contractors, particularly departmental programming conventions and standards.
- Identifies strategic needs in technical knowledge and implements these for the statistical programming function.
- Partners with biostatisticians and clinical data management staff to establish clinical data collection, management, and/or data reporting standards.
- Communicates progress, milestones, and issues to department management.
- Communicates well with outside departments and/or groups and completes Ad-hoc requests as needed.
SUPERVISORY RESPONSIBILITIES:
- Directly supervises employee(s) and via other subordinate supervisors.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:
- BS/BA degree in related discipline and a minimum of 18 years of related experience; or,
- MS/MA degree in related discipline and a minimum of 16 years of related experience; or,
- PhD in related discipline and a minimum of 15 years of related experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
- Typically requires at least 16 years of related experience and/or a combination of experience and education/training.
- Experience in the Biotech/Pharmaceutical industry.
- A minimum of 10 years of clinical trial programming experience.
- Experience recruiting, hiring, and supervising programmers.
- Experience authoring SOPs and work instructions
- Experience in oncology and study Phases 1-III and NDA/BLA submissions highly desirable.
Knowledge/Skills:
- Good managerial and organizational skills.
- Good written and verbal communication skills.
- Knowledge of appropriate FDA regulations, industry standards, and guidance documents.
- Understand the clinical research process, trial designs, and the development of protocols and analysis plans.
- Shows expert knowledge of the SAS programming language, including SAS Base/Macro/STAT/Graph/ODS.
- Proficient in computer skills relevant to programming and analysis environments.
- Expert knowledge of CDISC standards and FDA data-submission standards.
JOB COMPLEXITY: WORKING CONDITIONS:
- Environment: primarily working indoors
- Some travel may be required
#Li=CW1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $252,500 - $359,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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Exelixis
paid holidays, sick time, 401(k)
Mar 04, 2025