Associate Director, Statistical Programming

CytokineticsOnsite

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.

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.Salary Pay Range$198,000 - $242,000USDOur 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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

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
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
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

Life at Cytokinetics

We are a leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. A number of commonly used drugs and a growing body of research validate the role that the cytoskeleton plays in a wide array of human diseases. Our focus on the cytoskeleton enables us to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease, fungal diseases and other diseases. We have developed a cell biology driven approach and proprietary technologies to evaluate the function of many interacting proteins in the complex environment of the intact human cell. We believe that our approach enhances the speed, efficiency and yield of our drug discovery and development process by accurately and rapidly identifying drug candidates with attractive properties. Our approach has yielded two drug candidates for the treatment of cancer, a drug candidate for the treatment of acute congestive heart failure and more than ten other research programs. Our most advanced drug candidate, SB-715992, is the subject of a broad Phase II clinical trials program designed to evaluate its effectiveness in many different types of cancer. An investigational new drug application, or IND, was filed with the U.S. Food and Drug Administration, or FDA, in 2003 for our second cancer drug candidate, SB-743921, which we expect will enter Phase I clinical development in early 2004. SB-715992 and SB-743921 are being developed through our strategic alliance with GlaxoSmithKline. In addition, we expect to initiate Phase I clinical development for a drug candidate, CK-1213296, for the treatment of acute congestive heart failure in the second half of 2004.

Thrive Here & What We Value1. Passionate about robust scientific thinking grounded in integrity and critical thinking2. Celebrates differences among employees3. Patient-centric approach to all actions and decisions4. Values integrity, ethics, doing the right thing, and being our best selves5. Emphasis on patient-centered care6. Focus on innovation and continuous improvement7. Dedicated to keeping the patient front and center in all actions and decisions8. Values-driven and sustainable approach to drug discovery and development9. Rigorous scientific thinking and critical thinking10. Emphasis on collaboration across different departments and teams