Associate Director, Data Programming

3 weeks ago

Cary, United States Allucent Full time

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for an Associate Director, Data Programming & Analytics to join our A-team (hybrid*/remote). As a Associate Director, Data Programming & Analytics at Allucent, you are responsible for leading the data programming and analytics activities for clinical trials and modeling & simulation projects, across multiple projects, within the Clinical Pharmacology, Modeling and Simulation (CPMS) business unit of Allucent. In this client facing role, The Associate Director will work with Allucent scientists, project managers, business development, and clients to ensure that data programming and analytics activities are accurately scoped, and efficiently delivered according to project timelines and budget. Responsibilities include contribution and review of analysis plans, production, and review of input files for model development, programmatic generation of report quality tables, listings, and figures (TLFs), implementation of CDISC for clinical, and analysis datasets (SDTM, and ADaM), and authoring data transfer agreements to support client projects and studies.

As a matrix leader, the Associate Director will define and optimize efficient workflows, practices and roles and responsibilities to ensure operational excellence for CPMS delivery of pharmacokinetic (PK) PK/pharmacodynamic (PD) analysis objectives for Allucent and sponsor conducted clinical trials, and/or modeling projects as required. The incumbent will contribute to cross-business programming initiatives as required. The Associate Director is accountable for maintenance and update of CPMS programming standards, such as data set requirements and standard tables, listings, and figures (TLFs) and ensures planning, preparation, and execution of production activities in accordance with the standard operating procedures, regulatory guidelines, executed client contract, and the clients' requirements.

Additionally, the Associate Director may serve as a scientific and technical resource for other CPMS functional areas outside of Programming, as appropriate, depending upon applicable training and experience.

In this role your key tasks will include:

  • Demonstrate expertise in the use of the R/SAS programming languages for client data programming and analytics for PK and modeling projects.
  • Exercise innovation, creativity, and problem-solving skills.
  • Develop code for formatting of study data for PK, PK/PD and modeling analysis and reporting in CDISC-compliant format (i.e., SDTM, ADaM, SEND), supporting industry standard software, such Phoenix Winnonlin, NONMEM and/or Monolix.
  • Develop and maintain PK, PK/PD programming standards such as PK TLFs, exploratory data analysis and visualization templates, and Markdown reporting templates.
  • Work directly with clients to facilitate transfer of data in the appropriate format, to resolve data queries, and to document outcomes of client interactions.
  • Develop and maintain best-practices, processes standard operating procedures for programming and data analytics activities.
  • Ongoing development of skills in the use of R/SAS programming tools to increase efficiency and quality of project deliverables.
  • Direct and oversee planning and technical aspects of quantitative analysis programming activities.
  • Collaborate with other functions within Allucent (e.g., Biometrics Business Unit) including fulfilling tasks pertinent to programming to ensure the quality and appropriateness of final deliverables.
  • Support business development and marketing activities and foster client relationships.
  • Maintain and develop organizational culture, values, and reputation.
  • Act as Allucent representative externally as required.
  • Other responsibilities as required.
Requirements

To be successful you will possess:
  • Bachelor's degree required, preferably in science, math, statistics, computer science or related field
  • Experienced in clinical data programming and data visualization with R and/or SAS.
  • Minimum 6 years of relevant work experience
  • Minimum 6 years of experience in drug development and/or clinical research
  • Good knowledge of GxP
  • GDPR/HIPAA and applicable (local) regulatory requirements
  • Strong written and verbal communication skills including good command of English language
  • Representative, outgoing and client focused
  • Ability to work in a fast-paced challenging environment of a growing company
  • Strong analytical skills
  • Representative, outgoing and client focused
  • Ability to work in a fast-paced challenging environment of a growing company
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required
  • Proficient understanding of PK and/or modeling and simulation science
  • Strong leadership skills
  • Strong presentation and networking capabilities
Benefits

Benefits of working at Allucent include:
  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees


Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

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