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AbbVie Director, Early Oncology Statistics in Redwood City, California

Director, Early Oncology Statistics

USA, California, Redwood City

1 additional location

USA, California

Research & Development

Requisition #1901848

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be in early-stage oncology development and can be based in South San Francisco or Redwood City.

KEY RESPONSIBILITIES:

Clinical Development:

  • Works collaboratively with multiple stakeholders to develop scientifically appropriate development strategies. Represents statistics, programming, and data management in assigned Asset Development Teams (ADT's) to provide functional area input to compound development. Ensures that clinical development program incorporates sufficient statistical and scientific rigor and quality to meet stated objectives and global regulatory needs, and ensures alignment with functional management

  • Reviews study protocols, authors statistical sections of protocols, develops statistical analysis plan and analysis specification for programming implementation

  • Ensures scientific protocols are scientifically and statistically sound and make optimal use of the data to be collected. Ensures research hypotheses and corresponding study designs are aligned with the project strategy, and meet scientific and/or regulatory needs

  • Ensures statistical methodology is appropriate, consistent with the objective(s) of the scientific protocol.

  • Leads the effort in developing innovative statistical methods that are aligned with the project strategy, and applies scientific rigor to methods of analysis and interpretation results.

  • In collaboration with Data Sciences, Statistical Programming and other stakeholders, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases are implemented such that short- and long-term project needs can be achieved.

  • Provides in-depth scientific/statistical review and ensures accuracy and quality of the statistical component of scientific reports and/or publications.

  • Provides analytical and strategic leadership for exploratory activities such as biomarker development, and due diligences.

  • Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided.

  • Manages CROs to ensure quality deliverables are completed within pre-determined timeline and budget.

Functional Area:

  • Participates in and contributes to scientific/statistical seminars and review forums.

  • Contributes to the improvement and standardization of global functional processes and procedures.

  • Builds external scientific contacts which foster professional development and promote the reputation of the department.

  • Mentors other development stakeholders with regards to statistical methodology and departmental operations.

  • Mentors and/or manages personnel when appropriate. Ensures continuous development of staff through internal and external training opportunities. Gain expertise on and provide training on innovative methods to staff when necessary. Responsible for providing strong professional and technical leadership to maintain a highly motivated staff. Ensures that self and staff are compliant with training requirements.

Basic:

  • Ph.D. in Statistics or Biostatistics with 8+ years of experience in Biopharmaceutical R&D or other relevant background in clinical research

  • Up-to-date expertise/knowledge in advanced statistical methodologies related to clinical trial designs, statistical modeling and data analyses, biomarker analysis

  • Excellent oral and written communication skills

  • Should have Therapeutic Area experience in Oncology for minimum of 2 year

  • Experience in early clinical development (Phase 1-2) is highly preferred

  • Experience in direct managing or supervising staff for minimum of 2 years

Experience and/or Competencies Required:

  • Expert knowledge and experience in applying statistical methods to drug development

  • Proficient communication and collaboration skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)

  • Excellent project management skills (including ability to manage scope and effectively to delegate to staff, contractors, external vendors, and other functions when appropriate)

  • Proficient strategic agility (including problem-solving and critical thinking skills, ability torive and/or influence drug development strategies)

  • Excellent drive for results (demonstrates interest and ability to learn fast, grasps the ‘essence’, and adapt quickly when indicated, takes initiative, welcomes problems as challenges and finds solutions to technical problems)

Key Leadership Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance

  • Creates a learning environment, opens to suggestions and experimentation for improvement

  • Embraces the ideas of others, nurtures innovation and manages innovation to reality

Additional Information

  • AbbVie is an Equal Employment Opportunity employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

  • Travel: Yes, 10 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time

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