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Senior Supervisor, Clinical Programming


Shanghai City, IL 61412
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Job Details

**Primary Responsibilities** **General**

+ Designs and plans statistical algorithms and code in conformance with a globally aligned Systems Development Life Cycle (SDLC) and programming standards, such as Pfizer clinical data standards, and are in compliance with relevant SOPs and the applicable regulatory guidelines for the assigned clinical development programs

+ Accountable and responsible for quality and timely delivery of standard and non-standard data sets, tables, listings and figures that are required for the study reports, submissions and product defense and commercial support based on the final synopsis and analysis plan.

+ Ensures timely and quality programming documentation for inspection readiness, including Analysis and Reporting Plan (ARP), BDR issue log and other related programming documents

+ Provides input into the design and development of project plans: provide planning, development and delivery of analyses, (tables, listings and figures) for use in scientific reports, clinical trial results, publications, regulatory response and commercialization

+ Delivers according to the overall protocol timeline and quality goals through matrix communication within the Study Team

+ Develops and maintains TA specific knowledge base for clinical programming practice and coordinates experience sharing across studies, e.g. best practices, lessons learnt, metrics of trends analysis, etc.

+ Communicates effectively within the teams and functional lines

+ Maintains responsibility and metrics on quality control process for CPW deliverables

**Hands-on** **clinical programming responsibilities:**

+ Works under the guidance of Clinical Programming Lead (CPL) to proactively plan, assess workload, establish timelines, and prioritize activities for the analysis and reporting of clinical study data.

+ Contributes to timely and quality programming documentation at study level

+ Reviews and provides feedback on protocol, CRF, SAP and other study-related documents to ensure all programming requirements are met

+ Performs hands-on programming activities (generation and QC of tables/listings/figures/datasets) and provides technical expertise to support data reporting for clinical trials

+ Provides programming algorithm support as needed

+ Produces PK/PD analysis data files and data presentations according to corresponding processes and standard (PK/PD Programmer)

**Clinical Programming Lead** **responsibilities:**

+ Serves as the primary clinical programming point of contact for study team

+ Performs hands-on programming activities as needed

+ Accountable for the implementation of clinical programming activities for studies and submissions Establishes strategy, timelines, resourcing and project management for the analysis and reporting of clinical study data working with drug development project teams and department leadership.

+ Ensures appropriate documentation across the lifespan of the study and asset for all programming deliverables, and verifies the proper TMF filings, as appropriate, to ensure accurate records supporting oversight and quality for inspection readiness.

+ Ensures planning is in place and implemented for all programmed deliverables, including consideration of special data types (e.g., adjudicated endpoints, biomarkers, PK/PD data, patient-reported outcomes, non-CRF data, serology lab results) and potential down-stream uses of data.

+ Works with hands-on programmers, statisticians and others to clarify points of ambiguity to ensure clear, concise, complete specifications for programmed deliverables.

+ Supports understanding of Pfizer Data Standards and analysis plan requirements and ensures strategy for data standard implementation is followed (e.g. CDISC or PDS)

+ Ensures that programming activities are conducted in compliance with SOPs and relevant regulatory requirements

+ Leads relevant study team meetings (e.g. BDR)

+ Provides technical oversight and guidance to hands-on programmers in all the programming activities at study level

+ Actively oversees Planisware project milestone s and manages inconsistencies through networkin g with relevant CPMs to ensure milestones are achieved

+ Accountable for the consistent practices (standard, process and documentation) within a project and ensures lessons learnt in one study are shared across all studies within a project

+ Helps CPMs to have direct access to the most relevant biometrics expertise at anytime

+ Partners with CDS to ensure full biometrics availability at anytime during different study stages

+ Serves as a contact for internal and external audits, as well as communicating with regulatory authorities with regard to clinical programming-related processes and activities at project level

+ Accountable for timely reporting of relevant project metrics on quality, speed and compliance to programming TA lead and ensures timely cross-TA sharing for lesson learnt and accomplishment in CPW

+ Drives quality gate activities for required C-BDM in-scope studies

+ Provides statistical programming subject matter expert (SME) support for specific areas to CPW

**Training & Education Preferred:**

+ Minimum of Bachelor's Degree or equivalent in statistics, computer science, mathematical science or related discipline; Master's Degree preferred

**Prior Experience Preferred**

+ Clinical Programming and industry experience in order to have understanding of the processes associated with clinical drug development and programming operations

**Technical Competencies:**

+ Clinical Programming expertise

+ Organizational skills

+ Communication skills

+ Project/process management

+ Clinical development process

+ Administrative excellence

+ Clinical/Scientific aptitude

+ Technology management

+ Problem solving / Decision Making

**Behavioral Competencies:**

+ Collaborative, supportive

+ Innovation

+ Influencing

+ Networking and Alliance Building

+ Learning Organization

+ Flexibility

+ Tactical Thinking

+ Teamwork

+ Initiating and Implementing change

+ Customer Focus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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