Senior Data Manager, Cytokinetics, Inc., South San Francisco

 

We are currently seeking an organized, motivated and detailed Senior Data Manager, in our Biometrics department who will be reporting to the Manager of Clinical Data Management 

 

The Senior Data Manager (SDM) will be responsible for managing the outsourcing of clinical studies to several contract research organizations (CROs) and for the execution of the data management lifecycle process (e.g. CRF design through Database Lock).  The SDM will coordinate with the clinical operations team to ensure the accurate and complete data collection for our global oncology and cardiovascular programs. The candidate will be the key contact with the CRO for Data Management related issues or problems and will liaise with internal customers to manage and resolve Data Management issues. The SDM is responsible for ensuring that Data Management deliverables are met.

 

Responsibilities (included, but are not limited to)  

 

á  Reviews, creates, and maintains the Data Management Plan throughout the life-cycle of the study protocol, which includes: CRF annotation, database specifications, edit checks, and other pertinent Data Management documents.

á  Provides leadership to and coordinates with the data management staff at the CROs to ensure database lock and release of data for analyses. Spear heads agenda and meeting minutes from CROs deliverables.

á  Monitors and tracks the quality of all data management deliverables  ensuring audit practices have been enacted to validate the quality and assurance of database content from CROs as well as other external electronic data transfers.

á  Reviews and reconciles Serious Adverse Events and Adverse Event data.

á  Reviews coded adverse events and concomitant medication data.

á  Reviews and generates patient profile listings for internal or external review, as well as laboratory data (e.g. Chemistry and Hematology) for discrepancies and communicates any outstanding issues, for CRO action and correction.

á  Coordinates and ensures smooth SAS datasets or electronic load data transfers from CRO's.

á  Reviews and understands study protocols and other clinical related materials.

á  Actively participates in clinical sub-teams presenting Data Management concerns and issues.

á  Interacts with Director of Biometrics, Manager of Clinical Data Management, Statisticians, Programmers, Clinical Trial Project Managers, Medical Monitor, and other personnel to provide support in the areas of data management.

á  Provides input on existing or new SOPs and other procedural documents to maximize productivity and efficiency with the Biometrics department.

á  Maintains an overall knowledge of regulatory guidelines, industry standards, and new technologies.

á  Responsible for assigned studies or ongoing projects to ensure that work is proceeding in an efficient manner and that project' timelines are met.

á  Communicates project status and key project issues to Manager of Clinical Data Management.

á  Communicates back to clinical sub-team with post-mortem investigation of previous studies (e.g. lessons learned) for study design and continuous improvement of new studies.

 

Requirements:

á  Minimum of 4 to 5 years experience as a Senior Data Manager working within a pharmaceutical or CRO environment, with overall exposure from inception to conclusion in managing Phase I, II and III clinical studies.

á  Minimum of 1 to 2 years managing external vendors for Data

á  Management in a leadership capacity.

á  Minimum 2 to 3 years proficiency in the use of clinical database or systems such as EDC, IVRS, Oracle Clinical, ClinTrial, and Integrated Review.

á  Understanding of Clinical Data Interchange Standards Consortium (CDISC) and SAS(r) terminology.

á  Therapeutic experience in oncology and cardiovascular is a must.

á  Ability to proficiently use Microsoft products (Excel, Word, PowerPoint and Outlook).

á  Bachelors Degree or equivalent in life science, computer science, business or related discipline.

á  Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.

á  Thorough knowledge of applicable regulatory rules and guidelines, including ICH group.

á  Complex and/or international trials experience.

á  Demonstrated proficiency in the data management processes.

á  Possesses excellent interpersonal communication skills (written and verbal)

á  Strong attention to detail and ability to work independently

á  Possesses a positive attitude and works well with others.

 

Manager, Biometrics, Cytokinetics, Inc., South San Francisco

 

We are currently seeking, a motivated candidate to become a part of the growing Biometrics (Biostatistics, Statistical Programming, and Clinical Data Management) team.

 

Responsibilities:

á  Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams

á  Responsible for writing statistical methodology section of the protocol, including sample size calculation

á  Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE

á  Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities

á  Direct the activities of internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place.

á  Review, and comment on CRFs, annotated CRFs, and edit checks documents.

á  Participate in operations meetings and address issues related to biostatistics.

á  Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports (including review and comment on draft version of TLFs).

á  Perform additional analysis and data validation.

á  Develop and contribute to Biometrics SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

 

Qualifications:

á  Masters degree in biostatistics with a minimum of 8 years experience in the pharmaceutical industry.

á  Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.

á  Experience in Biostatistics & SAS programming in a regulated clinical research environment

á  Experience in organizing regulatory submissions,

á  Experience in BLA, NDA/s NDA submissions.

á  Strong leadership skills and team work spirit.

á  Experience in the oncology/cardiovascular therapeutic area.

 

Statistical Programmer, Cytokinetics, Inc., South San Francisco

 

We are currently seeking, a motivated Statistical Programmer to become a part of the growing Biostatistics, Statistical Programming,  and Clinical Data Management team.

 

Responsibilities:

á  The Statistical Programmer will interact with Statisticians, Clinical Trial Project Managers, and other personnel to provide programming support in biostatistics and data management.

á  Responsible for all statistical programming activities, indication or publication activities, and data base structure at Cytokinetics.

á  Provide statistical programming support to generate derived analysis data sets, tables, listings, and  figures for individual studies and ISS/ISE;

á  Participate in the review of statistical analysis plans, draft table specifications, design analysis data sets, and provide mapping files for analysis data sets.

á  Review, and comment on CRFs, annotated CRFs, and edit checks documents.

á  Participate in operations meetings and address issues that may influence statistical programming.

á  Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports.

á  Perform additional analysis and data validation.

á  Cooperate with CRO statistical programmers and validate their work.

á  Develop and contribute to Biometrics SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

 

Qualifications:

á  Bachelor degree in biostatistics, or computer science, with a minimum of 5 years experience as a Statistical Programmer in the pharmaceutical industry.

á  The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.

á  Experience in SAS programming in a regulated clinical research environment

á  Experience in organizing regulatory submissions,

á  Experience in BLA, NDA/s NDA submissions.

á  Strong leadership skills and team work spirit.

 

Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.

                                                                                                                                

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Charles Jo

Senior Recruiter, Cytokinetics, Inc.

Office 650.624.2927 | cjo@cytokinetics.com

 

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