Senior Manager, Biostatistics

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 198,000 - 231,000; Full time

Benefits offered by this job

Stock options/RSUs

Health, dental, vision insurance

401k with employer match

Paid time off

Learning and wellness stipends

Job summary

Cytokinetics, Inc. is seeking a Senior Biostatistics Manager to guide design and analysis of clinical studies, applying statistical expertise to inform trial strategy and regulatory interactions.

The role emphasizes developing SAPs, analyzing complex data, and contributing to CRFs, while collaborating with cross-functional teams and leveraging ML/AI techniques to enhance insights from biomedical datasets.

Qualifications

• Ph.D./MS in Statistics/Biostatistics with biotech/pharma experience.
• Solid technical foundation in statistics and trial design.
• Proficiency in SAS and/or R; able to translate analyses into actionable insights.
• Experience with high-dimensional or biomarkers and regulatory contexts.
• Strong written and verbal communication for cross-functional audiences.

Responsibilities

• Provide statistical support and strategic input to clinical development plans and target product profiles.
• Draft and review protocols, SAPs, and CRFs to align with trial goals.
• Perform analyses per SAPs, handling novel endpoints or biomarkers.
• Collaborate with study teams to meet deliverables and define processes.
• Summarize findings clearly and communicate implications to stakeholders.
• Contribute to clinical study reports and regulatory submissions.

Skills

SAS proficiency

R proficiency

Statistical analysis

ML/AI familiarity

Cross-functional collaboration

Scientific communication

Education

Ph.D./MS in Statistics/Biostatistics

Tools

SAS

R

ML/AI concepts

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. Senior Biostatistics Manager is a critical partner in the design and analysis of clinical studies, applying statistical expertise to guide trial strategy, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional and/or observational data to inform clinical plans, go/no-go decisions and regulatory interactions. Successful candidate will combine solid statistical background with advanced machine learning techniques to help to transform how Cytokinetics generates insights from clinical trials and other biomedical datasets.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Under guidance, provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and Phase1-4 trials designs, contributing to team’s preparation for company governance reviews.

Draft and review protocols, SAPs, and CRFs using established templates and examples, ensuring alignment with trial goals such as safety and efficacy assessments and translational objectives.

Perform or support statistical analyses per SAPs, including working with novel endpoints or biomarkers, and proactively identify future uncertainties.

Collaborate with study teams to meet deliverables and develop appropriate processes.

Summarize findings clearly, with support as needed, translating complex outputs into actionable insights.

Contribute to clinical study reports and regulatory submissions, supporting documentation for relevant regulatory interactions including INDs, EMA scientific advice, and other HA interactions.

Apply judgment to solve moderately complex statistical or data issues, and know when to seek guidance when facing novel or ambiguous situations.

Be an active participant in department initiatives contributing to best practices, and guidelines.

Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Play an active part in internal innovation by evaluating novel approaches, supporting capability building, and aligning with Cytokinetics AI/ML efforts.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

Education/Experience: Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 0-2 years (for Ph.D.) or 5+ years (for M.S.) of experience in the biotech/pharma industry or at research institutions as a statistician.

Possess a solid technical foundation in statistics.

Proficient in SAS and or R and generally comfortable with programming concepts.

Demonstrate independent thinking and make decisions based on sound principles.

Demonstrate excellent strategic agility including problem solving and critical thinking, with agility that extends beyond the technical domain.

Have excellent verbal and written communication skills in presentation and writing, with the ability to explain complex technical concepts in clear language.

Preferred qualifications:

Experience working with cross-functional collaborators.

Effective communication skills with the ability to translate complex, often exploratory or model-based statistical concepts for non-statistical audiences, including clinicians and researchers.

Basic understanding or willingness to learn drug development principles.

Ability to providing statistical guidance in fast-paced, high-uncertainty settings.

Familiarity with ML and AI approaches.

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Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $198,000-$231,000. 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.

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.