Senior Director, Biostatistics

Cytokinetics Incorporated; South San Francisco (CA); Hybride; USD 286 000 - 334 000; Plein temps

Avantages offerts par ce poste

Stock options

Restricted stock units

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k retirement plan

Learning stipends

Wellness stipend

Paid time off

Résumé du poste

Cytokinetics Incorporated is seeking a senior biostatistics leader to guide statistical strategy for cardiovascular programs and post-marketing evidence generation. You will direct a team of biostatisticians, shape study designs, and collaborate with clinical and medical affairs to ensure regulatory-ready analyses.

The role emphasizes late-phase trials, real-world data studies, and adherence to FDA/EMA guidelines, with a hybrid-work model in South San Francisco.

Qualifications

• MS/MA or PhD in Statistics/Biostatistics or related field with 12+ years of clinical trials experience.
• Experience leading biostatistics teams and setting dept. standards.
• Knowledge of FDA/EMEA/ICH guidelines and CDISC standards.

Responsabilités

• Provide strategic input on Cytokinetics development programs.
• Lead biostatistics department and supervise statisticians.
• Oversee design, analysis, and reporting of late-stage trials and observational studies.
• Manage CROs and vendor relationships including scope, budgets, and timelines.
• Collaborate with clinical research and medical affairs for regulatory evidence.

Connaissances

People management

Biostatistics expertise

Clinical trials design

FDA/EMA guidance

CDISC standards

Vendor management

Communication skills

Formation

MS/MA in Statistics/Biostatistics

PhD in Statistics/Biostatistics or related

Outils

SAS

R

Description du poste

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.

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 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.

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.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

#LI-HYBRID

Cytokinetics is an Equal Opportunity Employer