Senior Director, Biostatistics

Cytokinetics, Inc.; South San Francisco (CA); Hybrid; USD 286.000 - 334.000; Vollzeit

Benefits dieser Stelle

Equity in stock options

Comprehensive health coverage

Dental coverage

Vision coverage

Life and disability insurance

401k retirement benefits

Learning and wellness stipends

Paid time off

Zusammenfassung

Cytokinetics, Inc. in South San Francisco, CA, is seeking a leader to guide the biostatistics function across late-phase and post-marketing studies.

You will set strategy, oversee trial design/analysis, and mentor statisticians while partnering with clinical research and medical affairs to support regulators, providers and payers. The role emphasizes strong regulatory knowledge, collaboration, and vendor oversight to deliver high-quality statistical work on multiple compounds under tight

Qualifikationen

• MS/MA or PhD in Statistics/Biostatistics with 12+ years of clinical trials experience.
• Experience leading Phase 3/4 trials and cardiovascular/neuromuscular studies.
• Strong regulatory knowledge and CDISC standards.
• Ability to manage budgets and CROs.

Aufgaben

• Provide strategic input on Cytokinetics development programs.
• Provide input on clinical development plans, including post-marketing evidence generation and safety signal seeking.
• Develop and implement department standards and practices and oversee process improvements.
• Provide technical oversight of statistical design, conduct, and analysis of late-phase trials and real-world data studies.
• Write and review protocols and statistical analysis plans and CRFs.
• Evaluate and manage CROs and vendors, including scopes of work, timelines and budgets.
• Build strong relationships within biostatistics and with other functions.

Kenntnisse

Leadership

People management

Biostatistics

Clinical trials

CDISC

Regulatory guidelines

Vendor management

Communication

Project management

FDA/EU experience

Ausbildung

Statistics PhD

Jobbeschreibung

About Cytokinetics

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 and Experience

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

Key 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

Pay Range

Location: #LI-HYBRIDFollowing the primary location of South San Francisco, CA, the expected salary range for this position 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 restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Benefits

• Equity in the form of stock options and/or restricted stock units
• Comprehensive health coverage
• Dental coverage
• Vision coverage
• Life and disability insurance coverage
• 401k retirement benefits with employer match
• Learning and wellness stipends
• Paid time off

Culture & Values

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered.

Equal Opportunity Statement

Cytokinetics is an Equal Opportunity Employer