Biostatistics Manager

SUMMARY/JOB PURPOSE:

Designs plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety efficacy and marketability of compounds. Projects prepares the statistical component of protocols which meet project objectives guidelines and clinical trial methodology standards.

Essential Duties And Responsibilities:

• Provide written and verbal recommendations on quantitative/statistical and data management issues.
• 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.
• Assist in performing data analysis interpretation of study results and may collaborate with clinical team to produce interim reports final reports and publications.
• May interact with and manage counterparts at CROs or companies collaborating with Exelixis.
• Interpret the project implications of regulatory guidelines.

Supervisory Responsibilities:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and 7 years of related experience; or
• MS/MA degree in related discipline and 5 years of related experience; or
• PhD in related discipline and 0 or more 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 3 years of related experience and/or combination of experience and education/training.

Knowledge/Skills:

• Expertise with SAS and or R programming is preferred.
• Developed and or reviewed SDTM/ADaM specifications.
• Experience in Oncology or similar related discipline.
• Knowledge of FDA/EMA regulations and guidance documents.
• Problem solving skills and sound statistical judgment.
• Attention to detail.
• Ability to effectively represent Biostatistics in multidisciplinary meetings.
• Ability to interact effectively with Biostatistical data management operations and clinical personnel from CRO and companies collaborating with Exelixis.
• Uses knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Performs a variety of task under only general direction.
• Identifies and implements methods techniques procedures and evaluation criteria to achieve results.
• Has good general knowledge of other related disciplines.
• Applies good analytical and business communication skills.

JOB COMPLEXITY:

• Works on difficult problems where analysis of situations or data requires a thorough solution.
• Exercises judgment within generally defined practices and policies in selecting methods techniques and evaluation of criteria for obtaining solutions.
• Uses professional concepts and companys policies and procedures to solve a range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.

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If you have a disability and need an accommodation in relation to the application and/or recruitment process please email us at: .

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment including dual monitors and ergonomic chairs to ensure a comfortable workspace.

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.