SUMMARY/JOB PURPOSE:

Applies extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.

Essential Duties And Responsibilities:

• Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
• Oversee programming of ADaMs and TLFs for the study.
• Responsible for one or more studies with concurrent tasks and timelines.
• Participate in the validation/QC of key study endpoint analysis and submission deliverables.
• Apply appropriate regulatory guidelines to the projects.

Supervisory Responsibilities:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 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:

• Experience in oncology and study Phases I-III highly preferred.
• Experience in Biotech/Pharmaceutical industry preferred.
• Experience with managing CROs in the conduct of clinical trials.
• Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
• Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.

Knowledge/Skills:

• Knowledge of appropriate regulations, industry standards and guidance documents.
• Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.
• Developed/reviewed SDTM/ADaM specifications
• Strong SAS programming knowledge.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.

JOB COMPLEXITY:

• Works 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:

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 $166,500 - $236,500 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.