Senior Director, Biostatistics

Cytokinetics; South San Francisco (CA); Hybrid; USD 286,000 - 334,000; Full time

Benefits offered by this job

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Job summary

Cytokinetics in South San Francisco, CA, seeks a senior leader to head the biostatistics function, guiding strategy, design, and analyses for multiple cardiovascular-focused trials, including late-phase and post-marketing studies.

You will recruit and mentor statisticians, set department standards, oversee external vendors, and ensure rigorous statistical methods while collaborating with regulatory and clinical teams.

Qualifications

• MS/MA or PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of clinical trials experience.
• Experience leading phase 3 and phase 4 studies.
• Knowledge of FDA/EMA/ICH guidelines for drug development.

Responsibilities

• Provide strategic input on Cytokinetics development programs.
• Provide vision and direction for department standards and practices and oversight of process improvement initiatives.
• Technical oversight of the statistical design, conduct, and analysis of late phase trials and real-world data studies including safety evaluation.
• Write and review protocols and statistical analysis plans.
• Evaluate and manage CROs and vendors including scope-of-work, timelines, and budgets.
• Lead and mentor biostatisticians and foster cross-functional collaboration.

Skills

People management

Communication skills

Statistical design

Clinical trial knowledge

FDA/EU/ICH guidelines

Cross-functional collaboration

Vendor management

Problem solving

Education

MS/MA in Statistics/Biostatistics or PhD

Tools

CDISC standards

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on late phase and post-marketing studies. Sets direction for statistical contributions to real world evidence generation. Develops and/or applies sound statistical methodologies to meet key project objectives, with special focus on Phase 3 and observational studies. Partners with clinical research and medical affairs to generate evidence for regulators, providers and payers. Recruits, develops, and supervises project statisticians. Takes a leadership role in developing and implementing biostatistics department policies, standards, practices, and work-instructions in coordination with other senior leaders. Conceptualizes and implements initiatives for process improvement and or standardization for biostatistics activities and deliverables. Provides strategic statistical guidance to anticipate challenges, mitigate risk, and ensure project success. Manages timelines, deliverables, and budgets of contract research organizations.

Essential Duties and Responsibilities

• Provide strategic input on Cytokinetics development programs
• Provides critical input on clinical development plans, including post-marketing evidence generation and safety signal seeking.
• Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives
• Provide technical oversight of the statistical design, conduct, and analysis of late phase clinical trials and real-world data studies including safety evaluation,
• Write and review protocols for soundness of trial design.
• Write and review statistical analysis plans and case report forms.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.
• Build strong relationships both within and outside biostatistics
• Direct management and supervision of biostatisticians by providing guidance to group members or teams based on organizational goals and company policy, with responsibility for results, costs and resourcing.

Education/Experience:

• MS/MA degree or PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of clinical trials experience

Preferred qualifications

• Experience working on clinical trials in cardiovascular or neuromuscular diseases
• Experience designing and analyzing observational studies
• Experience managing multiple statisticians.
• Has led phase 3 and phase 4 studies.
• Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.
• Knowledge of CDISC standards.
• Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines.
• Experience interacting directly with FDA and/or EU Authorities preferred.

Knowledge/Skills

• Strong people management and interpersonal skills
• Strong communication and collaboration skills
• Comprehensive and detailed knowledge of statistical experimental designs, analyses, and clinical trial requirements,
• Excellent knowledge of FDA/EU/ICH statistical guidelines.
• Has functional understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs, and drug safety.
• Project management and contract negotiation with outside vendors.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Applies strong analytical and business communication skills.
• Comfortable with ambiguity and complexity, and thrives in fast paced environment
• Exercises common sense and independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
• Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
• Ensures budgets and schedules meet corporate requirements.
• Creates networks involving coordination among groups.

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Pay Range:

The expected salary range for this position based on the primary location of South San Francisco, CA is $286,200-$333,900. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or