General Information

Location: Bala Cynwyd, PA, Remote

Organization: ACI Clinical

Job Type: Full Time - Regular

Description and Requirements

SUMMARY OF POSITION: A leadership role responsible for all data sciences-related activities at ACI. Sets the standard for team performance and provides mentorship and oversight in execution. This role is highly visible to ACI customers in providing expert guidance on the best practices for data sciences in expert committees.

EDUCATION REQUIREMENTS:

·       BS/BA required; Master’s Degree in Statistics preferred.

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

QUALIFICATIONS/EXPERIENCE:

  • Minimum eight (8) years industry experience.
  • Demonstrated technical expertise in SAS programming.
  • Ability to manage both local and remote resources

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • Supervise and mentor Data Sciences group including hiring and training of new employees, performance appraisals, and other standard managerial duties.
  • Assist in the cultivation of new business development opportunities, including preparing and presenting company capabilities for prospective clients, developing Request For Information/Proposals (RFI/RFP), and creating and approving study budgets.
  • Provide statistical programming support to multiple expert committees, including preparing case packets for adjudication committees and tables, figures and listings for data monitoring committees.
  • Author, review and approve company SOPs and related documents.
  • Oversee and assist in the validation and documentation of programming and data management software.
  • Maintain and improve upon structure for programming group, including but not limited to the creation of macro libraries, format catalogs, enhanced visual output displays, training presentation and documentation, and other programming methodologies.
  • Manage lead development and documentation of analysis datasets specifications.
  • Review statistical analysis plans and assisting in the design of statistical data displays.
  • Perform quality control of standard and custom data listings, summary tables, and figures, as well as derived data sets and accompanying specifications, and other client deliverables including data exports.
  • Oversee the generation of quality control reports including the quality and consistency of queries and organize and conduct database audits.
  • Oversee and assist with design of case report form design; database structure design and database acceptance testing; edit check specifications and their acceptance testing and all other data management related study documents.
  • Lead and manage conversion of clinical trials data to sponsor specific proprietary standards for repository building and data warehousing.
  • Coordinate all programming and data management tasks for current projects in ACI and satellite offices.
  • Implement and follow the latest versions of CDISC, FDA guidelines, Good Clinical Practice, and other industry standards.
  • Maintain and improve upon structure for programming group, including but not limited to the creation of macro libraries, format catalogs, enhanced visual output displays, training presentation and documentation, and other programming methodologies.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

SUPERVISORY RESPONSIBILITIES:

  • Provide leadership on all programming and statistical activities by directing and coordinating the data science team to support and accelerate committee services efficiently.
  • Oversight of all members of data Sciences carrying out supervisory responsibilities in accordance with organization policies and guidelines.
  • Directly supervise all nonsupervisory employees.
  • Ensure timely and quality deliverables in compliance to process and SOPs.
  • Interview, hire, train, assign project/tasks and complete performance appraisals for team members.
  • Author, review and approve company SOPs and related documents and ensuring department adheres to ACI Standard Operating Procedures (SOPs).
  • Ensure department adheres to ACI Standard Operating Procedures (SOPs).

TRAVEL REQUIREMENTS: 10%