Director, Statistical Programming Standards and Infrastructure

About the job

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

The Director, Statistical Programming Standards and Infrastructure (SPSI) will report to Sr. Director, statistical programming (SP). This role will be responsible for the development and implementation of a comprehensive, deeply strategic vision that connects together infrastructure, standards, and analysis and filing needs into a magnificent end-to-end flow of data flow with minimal transformations towards superb quality and efficiency across all studies, filings, and commercialization and safety work.

Responsibilities

• Lead a team of programmers on design, development, and maintenance of a cohesive, modularized library of departmental utilities developed primarily in SAS®
• Guide and supervise all working groups that develop, maintain, and implement standards with respect to labs, SDTM, ADaM, TLFs, and controlled terminology, and leverage all of these to drive efficient and high-quality infrastructure tool, template, and process development in keeping with proliferating regulatory and global standards guidance
• Partner with multi-functional leads as applicable, guide and supervise Statistical Programming working groups that develop, maintain, and improve standards for labs, SDTM, ADaM, Controlled Terminology, and TLFs, ensuring these standards align not only to current Industry and regulatory guidelines but also connect well to one another with minimal transformations in a way that facilitates formal analysis as well as regulatory reviews
• Build and maintain documentation describing the use of departmental SAS tools and standards
• Train Biometrics users on departmental utility and standards usage and processes
• Serve as domain authority for statistical computing environment-related activities and collaborate with multi-functional teams on implementation of third-party applications in support of SP activities
• Provide technical support to statistical programmers and call out as needed. Work with IT and other groups to resolve called out issues
• Assist in evaluating technical skills in SP candidates to help build a strong SP talent base
• Effectively engage in knowledge sharing with multi-functional teams and represent SP on projects facilitating Development-wide infrastructure and standards development initiatives
• As needed, provide hands-on programming support on activities such as coordinated analyses, clinical study reports, safety monitoring, manuscripts, conferences, and ad-hoc analyses

Participation

• Function as the lead or key advisor on multidisciplinary working groups that establish and govern data collection, transformation, reporting, and submission standards to optimize analysis and submission quality and consistency while minimizing data transformations between functions and systems.
• Function as a key participant on a Biometrics working group providing submission-related advice to study and filing teams. Help keep the group up to date on new regulatory developments in the global data submission space and apply new insights to infrastructure tools or departmental processes.
• Supply to procedures, standard methodologies, and process improvements across Biometrics and IT.

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.

Qualifications

• Bachelor’s degree with 12+ years of programming experience in the Biotech or Pharmaceutical industries
• Sophisticated SAS® skills with expertise in SAS/STAT, SAS/GRAPH, and the SAS® macro language
• 10+ years building SAS® utilities in support of crafting and testing datasets and TLFs on clinical trials
• 10+ years writing SAS® macros
• Validated domain guide on CDISC standards, BIMO deliverables, and regulatory requirements and mentorship for electronic submission of standardized data, including functioning as the lead on multi-trial electronic data submissions to FDA or PMDA
• Knowledge of clinical trial processes for data transformations, analysis, and governance
• Multiple contributions (papers or talks) to professional forums such as conferences or journals on the application of standards and/or departmental infrastructure design for SP work you’re doing
• Positive, professional demeanor and an ability to creatively use programming skills across variety of tasks in the Statistical Programming area
• Excellent written and verbal communication skills

Preferred:

• Experience in statistical programming automation technique solution
• Experience with R, C#, Visual Studio, Java, web applications; knowledge of relational databases
• Experience of training programmers on tools and processes.

Salary pay range: $225,000 – $275,000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.

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.

Cytokinetics is an Equal Opportunity Employer