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Date Added: Sat 18/07/2020

Senior Manager, Statistical Programming, Biometrics

San Diego, California, US
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Company: FATE THERAPEUTICS, INC.

Job Type: Permanent, FullTime

Senior Manager, Statistical Programming, Biometrics
362HY
Description
Fate Therapeutics is seeking an experienced statistical programmer to collaborate with
statisticians and data managers on the statistical programming strategy for multiple clinical
studies. This role will serve as primary in-house programmer on multiple studies. The
successful candidate will develop the programming strategy for clinical studies, case report
forms, database design, data management plans, programming specifications and statistical
analysis plans. This role is responsible for production and quality control of tables, listings,
figures, and analysis datasets. The successful candidate will develop strategy for
documentation of quality control of datasets and statistical analysis outputs and will
oversee the work of CROs that are performing any of the above listed tasks. This is a fulltime position and reports to the Vice President, Biometrics.
Responsibilities:
Lead statistical programing activities on cross-functional study teams to ensure
timely and quality support for required analyses
Provide oversight and technical consultancy for statistical programmers of
outsourcing vendors
Function as lead programmer in the development and quality control of tables,
listings, figures, analysis datasets, and/or systems in support of analyses utilizing
current industry standards including CDISC SDTM and ADaM
Provide programming input to Case Report Form development, Statistical Analysis
Plans, analysis file specifications, and tables, figures, and listings shells.
Provide programming support for the preparation of integrated reports, submissions
and post-submission activities
Be responsible for programming aspects of data integration and ad-hoc or
exploratory analyses for external presentations, regulatory submissions, and
responses to regulatory inquiries
Provide programming resource estimates and delivery timelines
Be responsible for the creation and revision of Programming Practice and SOPs
May supervise and/or mentor other programmers (internal and contracting)
Maintain project files that ensure adequate and clear documentation of statistical
analyses and quality control
Play a key role in meeting cross-functional goals through commitment, quality
standards, and a customer service orientation
Contribute to a work environment that fosters professionalism, mutual respect,
teamwork, and collaboration
Qualifications
BS/BA degree or equivalent in a relevant scientific discipline; medical or
mathematics/computer science background a plus
Minimum 6 years of prior experience as a Statistical Programmer using SAS within
the pharmaceutical, biotechnology or CRO industries
Supervisory experience a plus; Experience managing programmers preferred
Good communication skills; ability to work in a team environment with medical
personnel, clinical monitors, statisticians, data managers and medical writers
In-depth knowledge of FDA/ICH guidelines and industry/technology standard
practices
Detailed knowledge and experience in clinical study design, CRF design, central
laboratories, programming databases, query resolution, data validation
Knowledge of regulatory requirements for dataset submissions and relevant handson experience
Good understanding of clinical data and pharmaceutical development
Demonstrated proficiency in using SAS to produce derived analysis datasets and
produce tables, figures and listings (TFLs)
Thorough understanding of clinical data structures, relational database structures,
and data exchange with alternate data formats
Demonstrated expertise in the handling and processing of upstream data, e.g.,
multiple data forms, workflow, EDC, SDTM
Demonstrated expertise in providing outputs to meet downstream requirements,
e.g., ADaM, Data Definition Table, e-submission
Good knowledge of statistical terminology, clinical tests, medical terminology, and
protocol designs
Experience in oncology clinical trials preferred
Experience with complex graphing techniques desired
Knowledge in other programming languages such as R and Python desired
Ability to manage multiple and diverse issues and the ability to problem solve
Ability of managing CRO and external vendors
Collaborative teamwork and interpersonal skills that demonstrate initiative and
motivation
Working Conditions and Physical Requirements
Ability to travel up to 10% of time
The preceding job description indicates the general nature and level of work performed by
employees within this classification. Additional and incidental duties related to the primary
duties may be required from time to time.
For consideration send cover letter and curriculum vitae to:
and reference job 362HY.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the
development of first-in-class cellular immunotherapies for cancer and immune disorders.
The Company has established a leadership position in the clinical development and
manufacture of universal, off-the-shelf cell products using its proprietary induced
pluripotent stem cell (iPSC) product platform. The Company s immuno-oncology product
candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are
designed to synergize with well-established cancer therapies, including immune checkpoint
inhibitors and monoclonal antibodies, and to target tumor-associated antigens with
chimeric antigen receptors (CARs). The Company s immuno-regulatory product candidates
include ProTmune , a pharmacologically modulated, donor cell graft that is currently being
evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a
myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in
patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For
more information, please visit .
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