Manager, Clinical Programming

Location
Sunnyvale, CA
Posted
Feb 15, 2018
Ref
2265
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us at http://www.pharmacyclics.com/

Job Description:

General Position Summary / Purpose:

  • The Manager, Clinical Programming position is responsible for managing the clinical programming group within the Biometrics department to support EDC/vendor data cleaning, clinical trial monitoring, MedDRA/WHODrug dictionary coding, and data standardization activities in compliance with CDISC CDASH/SDTM standards.

ยท This position also performs hands-on clinical and statistical programming tasks for one or more studies. This role may also be responsible for developing automation program, evaluating software tools/SAS macros/utilities to automate programming tasks and support Biometrics team collaboration.

Key Accountabilities / Core Job Responsibilities:

Perform hands-on programming tasks for one of more studies Lead all clinical programming activities and provide backup for other programmers. Lead creation of intermediate lab datasets and help in lab data reconciliation.
  • Develop software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration
  • Manage clinical programming staff by appropriate assignment of responsibilities, defining scope, and reviewing activities/progress so that projects are delivered on time with suitable quality Collaborate with various teams within and outside Biometrics to assess project resource requirements versus current staff, including accurate prediction of future workload and adjust resource assignments to optimize staff performance Provide ongoing training, coaching, guidance, performance review, and career planning to staff Ensure self and staff are compliant with training requirements Represent the clinical programming group and give transparent information on team activities to customers/stakeholders via effective meetings and presentations Participate and lead standardization initiatives. Oversee efforts to determine and implement company standards related to CDISC CDASH/SDTM and programming conventions Responsible for monitoring regulatory guidance and industry best practices

    Qualifications / Requirements:

  • Experienced in managing programming staff.
  • Experience in Oncology clinical trial data.
  • Solid knowledge of CDISC standards.
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience:

    5 years of people and project management experience 9 years of SAS Clinical or Statistical programming experience in pharmaceutical/biotech industry within the biometrics department Experience in extracting and transforming EDC/CRF data Good understanding of CRF and study design Development of automation program using SAS and other programming languages. Documentation for study and programming activities SAS programming QC/validation experience Proven project management experience of programming activities in the clinical trials/pharmaceutical setting Design and development of programming deliverables (such as tables, figures, and listings) Knowledge on clinical coding conventions and dictionaries, such as MedDRA and WHODrug Organizational and time management skills Written and verbal communications skills Applied knowledge of Electronic Data Capture (EDC) systems and integrated data programming Accessing and processing database-related input and output Database support programming (edit checks, SQL, reporting) Transforming SAS datasets into other structures such as text, CSV, XML, XLS, or HTML formats Relational database structures, standard software, and their implementation Knowledge of software development lifecycle (SDLC) or other software development methodology Presentation skills

    Education/Certification:

      Bachelor's Degree or higher, in Computer Science, Statistics, Mathematics, or other related discipline is required SAS Institute certification is a plus
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