Associate Biostatistics Director

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.

• 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.

None

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.

• 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 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.

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.

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.