Senior Director, Biostatistics

Cytokinetics•South San Francisco, CA

2d•$286,200 - $333,900•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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.
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.

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.