Cytokineticsis 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.
At Cytokinetics each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious compassionate and collaborative individuals who are driven to make a positive impact.
TheExecutive Director of Biostatistics reporting to the Vice President of Biometrics is a senior scientific and strategic leader accountable for setting the vision strategy and execution of the Biostatistics function across Cytokinetics full R&D portfolio. This role serves as theprimary internal and external spokesperson for Biostatistics ensuring the function is strategically positioned as a critical driver ofdata-driven decision making evidence generation regulatory success and long-term value creation.
The Executive Director providescomprehensive leadership of the Biostatistics organization including talent strategy organizational design succession planning career development and performance management while fostering a culture of scientific rigor transparency accountability and operational excellence. The role is accountable formethodological integrity quantitative innovation and analytical qualityof statistical contributions across all development stages ensuring that high-quality data and rigorous analyses are translated intoclear actionable insightsthat inform program and portfoliodecisions.
As a core member of the development leadership team the Executive Directoractively shapes drug development strategyby embedding robust statistical thinking quantitative risk assessment and decision frameworks into study design endpoint selection and portfolio close partnership with Clinical Development Regulatory Data Sciences and other R&D functions this leader ensures thatdecisions at every stage of development are grounded in sound data appropriate assumptions and strong technical and regulatory foundations enabling confident and timely advancement of programs across the pipeline.
With a highly visible and collaborative presence across the organization this role plays a central part indriving cross-functional alignment strengthening Cytokinetics data-driven culture and generating compelling scientific evidenceto advance the pipeline and deliver meaningful therapies to patients.
Key Responsibilities
Define and execute thestrategic visionfor the Biostatistics function across the enterprise
Lead develop and inspire ahigh-performance biostatistics organization including talent development succession planning and performance management
Provide enterprise leadership instatistical methodology quantitative innovation and scientific rigoracross all programs and therapeutic areas
Embeddata-driven decision frameworksinto clinical development portfolio strategy and governance processes
Lead statistical strategy forclinical trial design analysis and interpretationacross all phases of development
Ensure biostatistics input and accountability for major documents including clinical development plans protocols clinical study reports and regulatory submission documents and summaries of safety and efficacy
Provide senior leadership inregulatory interactionswith FDA EMA and other global health authorities
Guide the use ofepidemiologic observational and real-world data methodsto strengthen development and submission evidence
Overseequantitative methods and analytics platformswith a focus on efficiency scalability and innovation
Serve as a key leader on theBiometrics Leadership Team shaping functional strategy and driving execution
LeadsponsorCRO relationships vendor partnerships and escalation management
Establish and governSOPs standards policies and operating modelsthat ensure quality compliance and inspection readiness
Represent Cytokinetics externally throughscientific leadership in industry academic and regulatory forums
Qualifications & Experience
Ph.D. in Statistics or Biostatistics with at least 15 years of biotech/pharmaceutical industry experience
Strong expertise in statistical methodology including best practices and new industry trends
Demonstrated proficiency in at least one statistical analysis software
Expert knowledge of ICH and other relevant regulatory development guidelines
Ability to explain complex statistical concepts and engage in scientific discourse
Outstanding executive communication and influenceskills
Proven leadership skills and ability to work effectively in a team environment
Demonstrated success in leadinghigh-performance cross-functional teams
Excellent organizational and problem-solving skills
Proven ability to driveorganizational change alignment and execution
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Pay Range:
In the U.S. the hiring pay range for fully qualified candidates is $307800-$359100 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidates geographic region job-related knowledge skills and experience among other factors.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. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.
Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.
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Cytokinetics is an Equal Opportunity Employer
Required Experience:
Director