Manager, Statistical Programming Resume Sample
Skylar Lubowitz
7400 Brent Extension,
Phoenix,
AZ
+1 (555) 597 3949
Work Experience
Manager, Statistical Programming
10/2017
-
PRESENT
Boston, MA
- Experience in developing software for clinical trials using the SAS system
- Good knowledge of statistics and drug development process
- Experience as a lead programmer for NDAs/BLAs
- Experience overseeing the work of internal contractors and external vendors (CROs)
- Familiarity with CDISC standards, including SDTM and ADaM models
- Responsible for all statistical programming activities within a therapeutic project or equivalent
- Lead, manage, develop and support statistical programming team
- Serve as project leader on studies or tasks of greater complexity
Senior Manager, Statistical Programming
02/2012
-
06/2017
Detroit, MI
- Attend multi-disciplinary team meetings, representing the statistical programming function
- Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
- Good knowledge with CDISC standards, including SDTM and ADaM models
- Provide statistical programming support to clinical trials for regulatory submissions and
- Shares knowledge and guides programmers in developing technical and analytical abilities
- Serves as a departmental resource in areas of technical expertise
- Attend multidisciplinary team meetings, representing the statistical programming function
- Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
- Using the SAS system, with 3 or more years of supervising SAS programmers
Manager Statistical Programming Western
01/2007
-
12/2011
Dallas, TX
- Skilled in programming with SAS. Knowledge of additional programming
- Experience overseeing the work of internal contractors and external
- Good knowledge with CDISC standards, including SDTM and ADaM
- Responsible for all statistical programming activities within Medical Affairs Biostatistics
- Program complex adhoc analyses in a fast paced environment for medical affairs/publication purposes working outside of the standard programming function for R&D clinical trials
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for Medical Affairs analysis requests
- Create and maintain department SOPs related to statistical programming
Education
Grand Valley State University
2002 - 2006
Bachelor's Degree in Biostatistics
Professional Skills
- Professional leadership skills coupled with exceptional communication skills
- Excellent problem solving, leadership, communication and interpersonal skills.Working knowledge of current regulatory requirements and guidance
- Excellent programming skills especially in SAS
- Advanced SAS and strong SAS Macro and reporting experience
- Experience in programming, system, and/or database documentation and validation
- Good communication skills in written and oral English
- Previous management experience or demonstrated leadership ability
How to write Manager, Statistical Programming Resume
Manager, Statistical Programming role is responsible for training, leadership, oncology, database, recruiting, analysis, reporting, design, research, modeling.
To write great resume for manager, statistical programming job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Statistical Programming Resume
The section contact information is important in your manager, statistical programming resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Manager, Statistical Programming Resume
The section work experience is an essential part of your manager, statistical programming resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous manager, statistical programming responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, statistical programming position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Statistical Programming resume experience can include:
- Solid Technical skills with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
- Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
- Extensive relevant industry statistical programming experience, with increasing levels of responsibility
- Experience in developing software for clinical trials using the SAS system
- Experience with estimating and preparing project budgets
- Independently validate SAS data sets and outputs from CROs or other programmers. Prepare
Education on a Manager, Statistical Programming Resume
Make sure to make education a priority on your manager, statistical programming resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, statistical programming experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Manager, Statistical Programming Resume
When listing skills on your manager, statistical programming resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical manager, statistical programming skills:
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
- Drive team members to improve their efficiency and effectiveness at prioritizing work and
- Prior experience participating in the production of NDAs, SNDAs PLA or PMAs
- Proven ability to prioritize projects and manage resources
- Demonstrated ability to multi-task and appropriately prioritize work assignments
- Having solid background of applied statistics
List of Typical Experience For a Manager, Statistical Programming Resume
1
Experience For Senior Manager, Statistical Programming Resume
- Assist analyst in developing best strategy for completing analysis in a timely manager
- Assist in Writing/maintaining department guidelines
- Participate in annual budgeting and reporting processes
- Generates or oversees the production of programming deliverables(e.g., tables, listings) for study reports and integrated summaries
- Guide programmers when they need assistance in programming
- Train and teach efficient programming techniques to programmers
- Provide programming support to analyze clinical data and generate reports and graphs on all AbbVie drugs in the clinical phase
2
Experience For Senior Manager Statistical Programming Resume
- Hire consultant programmers to meet short -term needs of additional programming resources
- Provide mentor to junior level staff in programming group
- Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group
- Possibly oversee work of internal contract programmers and external vendors
- Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project
- Manages a small team of programmers
3
Experience For Manager Statistical Programming Western Resume
- Designs and/or codes analysis files
- Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions
- Has the ability to resolve study related issues and conflicts within a therapeutic project
- Can create buy-in and support and has the ability to negotiate timelines
- Has the ability to directly supervise personnel
4
Experience For Manager Statistical Programming Resume
- Responsible for aligning technology solutions, such as Robotic Process Automation (RPA), Machine Learning (ML), and Artificial Intelligence (AI), and statistical software with Statistics and Statistical Programming business strategies
- Supervise, coach, and mentor staff
- Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
- Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges
- Supervise statistical programming group ; accountable for review and validation of all programmed results ;monitor and quantify efficiency' accuracy, and timeliness of group ; recruit, train, and orient all new hires
- Manage all the programmers in the statistical programming department
- Ensure technology updates occur as needed
- Ensure expenses for consultant programmers do not exceed the budget limitations
5
Experience For Manager, Statistical Programming Sdtm Resume
- Works with Director of Statistical Computing to establish and ensure adherence with programming and output standards and utilization of systems and processes to maximize efficiency of the statistical programming function
- Represent programming on the development and exploratory projects in a multidisciplinary project team to ensure timely and quality support for analysis and reporting
- Contribute to develop data models, programming standards, and trainings
- Develop collaborative work environment and be a positive role model
- Applies strategic decisions and recommendations to develop detailed programming strategy and plans the programming deliverables for projects of high complexity and/or scope
- Lead the design, development and maintenance of SAS® Applications/Tools/Utilities that support programming activities to ensure accuracy, completeness, quality, and timely delivery of statistical programming (SP) deliverables at the product and study level, in collaboration with Clinical Information Systems (CIS) department
- Serve as subject matter expert for statistical computing environment related activities, collaborate with cross-functional teams with implementation of third party/off the shelf applications supporting statistical programming activities, act as a SP business champion for technology where is SP is the system owner
- Providing SAS® technical support – act as first line support for statistical programmers and escalate as needed. Work with CIS, IT and other groups to resolve escalated issues
- Actively engage in knowledge sharing with cross-functional teams and represent statistical programming department on projects facilitating companywide infrastructure development initiatives
6
Experience For Manager, Statistical Programming Resume
- Experience with CDISC standard required
- Develop Infrastructure projects in support of increasing automation, standardization and validation of procedures and programs
- Coordinate timelines and allocate and resources for all programming activities for direct reports. Participate in department planning meetings
- To evaluate case reports forms ( design phase ) Statistical Analysis plans, software specifications, QC specifications, database and audit specifications
- To serve as a primary department contact and manage entire department in the absence of the director
- Assume all responsibilities of a Senior Statistical Analyst
- Implement pharmaceutical industry CIDISC standards
- Provide mentorship to all department staff
- Familiarity with multiple software products and platforms required
7
Experience For Senior Manager, Statistical Programming Resume
- Knowledge of the drug development process (Phase I through IV) and general regulatory requirements
- Write or review SDTM and ADaM specifications prepared in-house or by CROs
- Develop, maintain, and modify SAS programs for publication, Investigator Brochure (IB), Development Safety Update Report (DSUR), and ad-hoc analyses
- Review CRFs, edit check specification, data transfer plan, and statistical analysis plan
- Collaborate and coordinate the development of study plan and timeline with various internal departments and CROs
8
Experience For Senior Manager Statistical Programming Resume
- Design and develop internal standard macro utilities
- BS in Statistics, Math or Scientific Discipline
- Acts as the primary business contact and Subject Matter Expert for the IT organization for systems implementation and maintenance
- Review programming requests and distribute/delegate to appropriate staff members. Review programming priorities with staff members. Review conflicting priorities with the DAU leader as appropriate
- Provide training and mentoring for new staff. Share expertise and knowledge to inform current and future work
9
Experience For Manager Statistical Programming Western Resume
- Perform study-specific and cross-study reporting. Support automation of statistical programming tasks
- Represent Statistical Programmers in SCHARP management meetings, committee work, working groups and special projects
- Coordinate with the other programming groups to identify and address common issues
- Standardize work practices across studies where practical and participate in standardization efforts that impact more than one functional group
- Design and document quality assurance procedures, validation efforts, standard operating procedures (SOPs), and work instructions (WIs). Follow SCHARP software development lifecycle (SDLC) practices and processes. Support the maintenance of existing SOPs and WIs
10
Experience For Manager Statistical Programming Resume
- Formal management/supervision coursework
- Implements strategic initiatives
- Knowledge of laboratory data
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resource matters
- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: create TLFs to support submission Q&As in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory Committee Meeting
- Coordinates and oversees programming team activities and provides technical and project specific guidance to programming team members to ensure quality and on-time deliverables in compliance with departmental processes. Including outsourced tasks to third party vendors and ensures their performance meets the agreed upon timelines, quality and budget established for the project or study
- Supervise, coach, and mentor staff Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges
- Six (6) years relevant industry statistical programming experience, with increasing levels of responsibility Previous management experience or demonstrated leadership ability Proven ability to prioritize projects and manage resources Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
List of Typical Skills For a Manager, Statistical Programming Resume
1
Skills For Senior Manager, Statistical Programming Resume
- Hands on experience in incorporating RPA, ML, and AI solutions into existing processes
- Experience creating CDISC ADaM datasets and using SDTM datasets is highly desirable
- Experience in performing analysis to support publications, conference presentations and internal decision making
- Experience managing other programmers and overseeing the work of internal contractors and possibly external vendors (CROs)
- Experience in the pharmaceutical industry generating analysis , reports and graphs for individual studies and ISS, ISE, NDA submissions to FDA
- Programming experience in the pharmaceutical industry o
- Experience in developing software for clinical trials
2
Skills For Senior Manager Statistical Programming Resume
- Demonstrated ability to communicate programming issues with non-technical staff
- Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis
- Solid knowledge of new advanced statistical methods using SAS and R
- Significant work experience in similar position managing Statistical Programmers
- Experience with creation and review of CDISC-formatted electronic submission deliverables is desirable
- Good knowledge of statistics methods such as GLM, Survival Analysis and the drug development process
- Experience as a lead programmer for a project and/or compound within the medical affairs environment
- Balance and prioritize multiple assignments and respond quickly to adhoc requests
3
Skills For Manager Statistical Programming Western Resume
- Experience with C++, C#, Visual Studio, .NET, JAVA, XML, HTML5 etc
- Experience with SAS Server 9.4, SAS Office Analytics, SAS Visual Analytics
- Experience with SAS statistical software is essential, preferably on a Unix platform
- Demonstrated ability to successfully manage a full workload across multiple-projects. Ability to manage and motivate direct reports
- Previous clinical trials and analysis experience
4
Skills For Manager Statistical Programming Resume
- Validate SDTM, ADaM, and tables/listings/graphs generated in-house or by CROs
- Experience as a senior statistical programmer level in a FDA regulated pharmaceutical or CRO environment
- Having knowledge of all phases of drug development, including early and late phase clinical development and submission
- Understanding of data structures, standard software and implementation
- Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming
- Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials
- Assist in the operations of the Statistical Programming Department; provide programming oversight and direction to direct reports
- Designs and develops programs in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis
5
Skills For Manager, Statistical Programming Sdtm Resume
- Manage and monitor CROs by providing guidelines on study programming activities
- Exercise independent judgement in developing methods, techniques, and evaluation criteria for obtaining results
- Develop statistical programming standard operating procedures (SOPs) and work instructions
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
- Proficient use of database management and programming software
6
Skills For Manager, Statistical Programming Resume
- Client focused approach to work A flexible attitude with respect to work assignments and new learning
- Creates a learning environment, opens to suggestions and experimentation for improvement
- Produce accurate resourcing plans in conjunction with appropriate Project Team Members
- Implement and advise project statisticians on the use of department standardization tools when programming clinical data or system application deliverables
- Recruit, interview and recommend of hiring Statistical Programmers
- Develop analysis tools, including those outside the SAS language to expedite the analysis process and provide technical support to the SAS programmers
7
Skills For Senior Manager, Statistical Programming Resume
- Ensure programming deliverable in-house or by CROs
- Knowledge of advanced statistical procedures in SAS including LIFETEST, PHREG, MIXED, and GLM
- Responsible for the accuracy, completeness, quality, and timely delivery of clinical programming deliverables at the product and study level
- Is responsible for all programming activities within a therapeutic project or equivalent
- Provides primary and secondary programming support as needed
- B.S., M.S. or Ph.D. in statistics, computer science, mathematics or a related field, required
- Participate in committees, task force groups as needed
- Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the
- Provide all performance management activities for 0-5 statistical programmer
8
Skills For Senior Manager Statistical Programming Resume
- Education in statistics is highly desirable
- Lead a “virtual” global team as required
- Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook
- .Client focused approach to work
- We have a comprehensive benefits package and offer highly competitive remuneration
- Lead a “virtual” global team as required Education
9
Skills For Manager Statistical Programming Western Resume
- Meet percentage of travel and billability guidelines for staff, where appropriate
- Provide expertise and consultation, facilitate metrics collection and develop action plans in
- Knowledge in database structures and set-up
- Manage SAS programmer analysis, coordinate work activities and manage time lines for direct reports
- Provide input into all department time lines; serve as a liaison with other departments
10
Skills For Manager Statistical Programming Resume
- Assist in managing the daily operations of the Statistical Programming Department including acting as a primary contact, managing entire departments in directors absence and represent department at client meetings
- Provide statistical programming input into other disciplines’ activities and participate in interdepartmental processes
- Knowledge of a wide variety of technologies
- Knowledge of CDISC standardization practices
- Provide feedback to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals
- Develop and maintain programming macros to effectively support internal data review and monitoring. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basis
- Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming on projects using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Manage and coordinate programming following Regeneron standard
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