SUMMARY/JOB PURPOSE:

Partners with head of Clinical and Statistical Programming to set goals and standards, supervises and mentors programming staff, allocates resources effectively, identifies and implements improvements, and resolves issues related to personnel and clinical trials data analysis and statistical programming.

Essential Duties And Responsibilities:

• Oversees implementation of CDISC standards and creation of operational, SDTM, and analysis datasets (i.e., ADaM), assesses quality of data analysis programs, and develops automated analysis tools where appropriate.
• Oversees development of tools for clinical trial data cleaning and integrity efforts.
• Defines quality requirements and develops / implements quality practices, including SAS program validation procedures and documentation.
• May be responsible for data integration used for clinical summaries, documentation and/or creation and quality control of statistical submission components to regulatory agencies.
• Sets goals, does performance assessments, mentors, and provides professional development opportunities for staff.
• Defines, develops and implements procedures, guidelines and policies for good programming practices.
• Adheres to FDA regulations regarding training records, guidelines, and SOPs.
• Provides hands-on statistical programming support.
• Works on multiple tasks at the same time and prioritizes tasks to meet timelines on a regular basis.
• Helps to train new employees and contractors, in particular on study specifics and 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 in establishing standards for clinical data collection, management and/or reporting of data.
• Communicates progress, milestones and issues to function and department management.
• Communicates with outside departments and/or groups and completes ad-hoc requests, as needed.

Supervisory Responsibilities:

• Supervises the activities of direct reports.
• Performs annual evaluations for direct reports.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
• MS/MA degree in related discipline and a minimum of nine years of related experience; or,
• PhD in related discipline and a minimum of five years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of twelve years of related experience and/or combination of experience and education/training.
• Experience in the Biotech/Pharmaceutical industry.
• A minimum of five years of clinical trial programming experience.
• Experience supervising programmers.
• Experience in oncology and study Phases I-III 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.
• Understands 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.
• Experience authoring SOPs and work instructions.

JOB COMPLEXITY:

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.

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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $176,500 - $250,000 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.