Associate Director, Statistical Programming

Cytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Responsibilities

• The Associate Director of Statistical Programming will interact with Statisticians, Clinical Data Managers, Clinical Trial Project Managers, and other personnel to provide programming support for clinical studies and ad hoc analyses
• Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses
• Provide programming support to clinical data management including identifying, reporting, and resolving raw data issues
• Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
• Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
• Participate in study team meetings and address issues that may affect statistical programming.
• Support and participate in the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports.
• Perform ad hoc analyses and data validation.
• Cooperate with CRO statistical programmers and validate their work.
• Develop and contribute to Biometrics SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

Qualification

• Bachelor’s or Master’s degree in biostatistics, computer science, or related fields, Master’s degree preferred;
• 10+ years of biopharmaceutical experience as a Lead Statistical Programmer in the biotech or pharmaceutical industry.
• The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
• Proficient of SAS programming in a regulated clinical research environment
• Experience of leading late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
• Experience in BLA, NDA/sNDA and EMA submissions.
• Strong leadership skills and team work spirit.

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 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.

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Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications
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• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer