Description

The Senior Director, Biostatistics leads the Biometrics (Biostatistics, programming and clinical data management) activities for one or more clinical development programs. The Sr. Director independently provides strategic statistical input to drug development planning, including feasibility assessments, clinical development plans, endpoint selection, complex study designs including adaptive designs, study interpretations, and regulatory submissions. The Sr. Director oversees activities in support of timely and accurate delivery of statistical designs, study protocols, data oversight plans, statistical analysis plans, study reports, publications and regulatory submissions.

This position will have direct reports.

The position reports to the Vice President, Biometrics.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Provide leadership and expertise in day-to-day statistical operations and development of statistical methodologies, resolve complex operational and technical problems in support of Pliant objectives and projects, or as a resource to others.

• Responsible for statistical input to clinical development plans, clinical study concepts and protocols, clinical study reports, regulatory documents, scientific publications, internal and external meetings and presentations.

• Accountable for development, implementation and execution of statistical analysis plans that support clinical development plans and clinical protocols, to ensure statistical integrity, adequacy and accuracy.
• Accountable for production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) by providing oversight of the work performed by internal resources and/or CROs.
• Responsible for directly managing Biostatistics resources and indirectly managing Statistical Programming and data management resources to meet company objectives.
• Able to perform analyses independently and provide interpretation the work.

• Responsible for development, summarization and interpretation of study results, in close collaboration with the cross-functional study teams.
• Able to act as lead statistician for all global regulatory interactions including filings, written, oral and face to face interactions.

• Ensure all biostatistics activities comply with industry norms, health authority regulations, ICH/GCP guidelines and company SOPs.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• PhD or MS in statistics or related field.
• At least 12 years of pharma / biotech industry experience, including direct experience overseeing managing outsourced biometrics activities.
• Experience in respiratory, hepatobiliary, gastrointestinal, or cardiorenal indications preferred.
• At least 5 years of direct management experience.
• Prior NDA/MAA filing experience.
• Comprehensive knowledge of clinical trials methodology
• Proficiency in SAS required
• Proficiency in at least one other statistical language (eg, R)
• Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistics and drug development.
• Proven leadership experience within both mid and late-stage development phases, including selection of relevant clinical study endpoints, as well as regulatory submissions and health authority interactions.
• Proven track record of innovative approaches such as adaptive clinical trial design.

• Excellent interpretation and presentation skills and ability to communicate statistical concepts and data to non-statisticians.

• Able to collaborate effectively with internal, cross-functional and external study teams to meet project timelines.

• Excellent organizational skills and attention to detail.
• Able to set priorities and juggle multiple projects and demands.
• Able to work independently while exercising initiative, flexibility and sound judgment.
• Ability to operate in alignment with Pliant’s values

The annual base salary for this role is $285K – $300K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.