Associate Biostatistics Director

Exelixis Inc; Alameda (CA); On-site; USD 166,500 - 236,500; Full time

Benefits offered by this job

401k plan with company contributions

Group medical, dental, and vision coverage

Paid vacation and holidays

Job summary

Exelixis Inc in Alameda, California is looking for an experienced clinical statistician to provide statistical recommendations and collaborate with various teams during clinical trials. The ideal candidate should have a strong background in statistics, with experience in oncology preferred.

This role involves authoring statistical plans, reviewing data, and managing external vendors to ensure quality deliverables. Competitive compensation includes a salary range of $166,500 - $236,500 and comprehensive benefits.

Qualifications

• Minimum 9 years of experience with MS/MA or 5 years with PhD.
• Experience in oncology and study phases I-III preferred.
• Strong knowledge of statistical applications and data management.

Responsibilities

• Develop clinical protocols with project teams.
• Review and author statistical analysis plans.
• Oversee CRO management for quality deliverables.

Skills

Knowledge of regulations

Strong SAS programming knowledge

Ability to interact effectively

Education

MS/MA degree or PhD in related discipline

Job description

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.

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 and QC of key study endpoint analysis and submission deliverables.
• Apply appropriate regulatory guidelines to the projects.

Supervisory Responsibilities

None

Education and 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 an equivalent combination of education and experience. May require certification in assigned area.

Preferred Experience

• Experience in oncology and study phases I-III highly preferred.
• Experience in biotech or 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.

Knowledge and 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.
• Developed or reviewed SDTM/ADaM specifications.
• Strong SAS programming knowledge.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manages 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.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.

Compensation and Benefits

The base pay range for this position is $166,500 - $236,500 annually, adjusted for geographic region. Benefits include a 401k plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. Employees may receive a discretionary annual bonus or, for field sales staff, a sales-based incentive plan. Company stock purchase opportunities and long-term incentives are also available. Vacation days: 15 accrued days in the first year; paid holidays: 17, including a company-wide winter shutdown in December; sick days: up to 10 per calendar year.

Equal Opportunity Employment

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.