DM Programmer, Associate Director

• As part of the Data Management Programming team, the Lead is responsible for the collection, documentation and programming of study and asset level data cleaning, study status metric, and monitoring report requirements. 

• Project level coordination and oversight of Data Management Programming tasks, including delivery tracking and resource estimations, to ensure consistent, timely and high quality application of process and delivery. 

• Works closely with Clinical Data Management department, Clinical Data Science Data Engineering and EDC Build teams, along with other cross-functional study team members to strategize and develop data cleaning reporting solutions that support the quality and timely delivery of data cleaning/quality checks, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 

• Ensures appropriate documentation across the lifespan of the study for all reporting deliverables. 

• Leads reporting discussions with internal stakeholders and external service providers  

• Provide programming expertise for data cleaning to efficiently ensure high quality data 

• Complies with applicable SOPs and work practices 

• Works with Clinical Data Standards and Clinical Data Management teams in the development of data cleaning/quality checks, study status metric, and monitoring reports standards. 

• Enhances available reporting tools/macros or creates new ones to support the review of clinical trial data and trial status information for cross-functional use and provides input on data management reporting standards as required 

• Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 

• Creates and tests listings for data review. 

• Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 

• Serve as a technical resource to teams for data visualization and reporting tools 

• Ensures operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Management 

• Directly supports knowledge development of others on data reporting and reporting tools that support the accuracy and integrity of study data 

• Identifies existing process/product improvements 

• Develops innovative, advanced new concepts that improve processes  

• Recognizes development needs and identifies/creates development opportunities within team 

• Supports the development of the Data Management Programming talent base and identifies development needs within the area of responsibility 

DIMENSIONS AND ASPECTS  

 Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)     

•  Comprehensive understanding of the pharmaceutical industry and programming expertise for data cleaning (e.g., clinical development, the prescription drug distribution process, etc) 

•  Technical expertise at the enterprise level, with a broader clinical data life cycle awarenes 

• Excellent communication skills and ability to ‘translate’ across functional lines 

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)  

• Demonstrated ability to work and influence across functions, regions and cultures 

• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing 

• Functional level leadership with the ability to inspire, motivate and drive results 

• Proven skills as an effective team player who can engender credibility and confidence within and outside the company 

• Ability to distil complex technical ideas in simple comprehensible terms in order to influence decisions and outcomes 

• Leads one or more assets at GPT level 

• Facilitates collaboration cross functionally in GPTs and generally within DSI and R&D 

• Enables the tactical execution of the SQS and DSI vision and mission 

• Leads and accountable for asset level strategies being implemented  

• Mentorship, matrix or direct management of  small team of SQS colleagues 

• Creates an internal and external sphere of influence in area of expertise 

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving) 

• Ability to make strategic decisions that impact the statistical programming function 

• Accountable for data management programming decision making  

• Participate in and/or lead initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions 

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships) 

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace 

• Ability to effectively implement R&D’s partnership strategy as it applies to statistical programming 

• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, medical directors, global program leads 

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking) 

• Forward thinking with the ability to recommend, influence and implement continuous innovation 

• Challenge the status quo and propose forward thinking innovative solutions 

• Implement and embed new ways of working utilizing a wide variety of software (e.g. SAS, R, Python) 

• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. 

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations) 

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity 

• Deep expertise required across statistical programming and computing environments   

• Ability to see and understand broader, enterprise level perspective and understand and assess impact to statistical programming 

• Ability to input into best practices with data sharing 

• Ability to input into programming and standardization for novel data such as real world data, digital data, wearable device data 

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with 8-10 years or Masters or doctoral degree with 6-8 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency  

• Minimum of 5 years of experience in a project lead role 

• Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 

• Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 

• Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills 

• Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas 

• Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), SAS and data visualization tools (e.g. BOXI, Spotfire, Tableau, RShiny, JReview) 

• EDC build and/or clinical data management experience preferred 

• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 

• Programming, specifically SAS and R, and other visualization tools hands-on experience 

• Assists with quality review of above activities performed by a vendor, as needed.  

• Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. 

• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.  

• Performs other duties as assigned within timelines.

​-This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

-In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.