Senior Manager, Data Standards (Remote)

Initial Therapeutics, Inc.; Hyde Park Township (IL); Remote; USD 90,000 - 140,000; Full time

Job summary

Join a forward-thinking company as a Senior Manager in Clinical Data and Reporting Standards, where you will play a pivotal role in shaping data standards for clinical trials. This exciting opportunity allows you to work with a cross-functional team of experts, ensuring compliance with industry standards while driving innovation in data collection and reporting. Your expertise in SDTM and clinical research will be crucial as you mentor junior team members and represent the company in industry projects. This remote role offers a chance to make a significant impact in a dynamic environment dedicated to improving health outcomes.

Benefits

Paid time off

Medical/Dental/Vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• Experience leading development of standards for data collection and reporting.
• Experience with preparing SDTM datasets for regulatory submissions.

Responsibilities

• Participate in developing data and reporting standards for clinical trials.
• Create and review SDTM Mapping Specifications and Trial Design Domains.

Skills

SDTM

CDASH

ADaM

Clinical Research

Education

MS in a relevant field

BS in a relevant field

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVies portfolio of clinical trials and ensures AbbVies conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.

Standards Development responsibilities include

• Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
  • SDTM mapping
  • Data Collection
  • Data Review Rules
• Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
  • Study-level tables, listings, or figures
  • Product-level safety analysis displays
  • ADaM mapping and derivation
• Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities
• Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)
• Develop training materials to the organization on the proper use of standards in pipeline activities
• Communicate ongoing standard development activities across the organization

Pipeline responsibilities include

• Create, review, and provide feedback on SDTM Mapping Specifications and Trial Design Domains
• Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC
• Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewers Guides for both FDA and PMDA submissions
• Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation

Other responsibilities include:

• Representing AbbVies interests in industry standards development projects
• Staying current with industry standards such as CDISC, and the regulatory requirements related to their use
• Identifying improvements to the processes and content of standards, and driving those improvements to completion
• Mentor junior team members

Qualifications

This is a remote opportunity that can be hired anywhere in the US

• Experience leading development of standards for data collection, tabulation, analysis and/or reporting
• Experience with SDTM is required
• Experience with CDASH is highly recommended
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful
• Active participation in CDISC teams preferred
• Experience with preparing SDTM datasets and documentation for regulatory submissions

Education and experience requirements

• MS with 9 years of relevant clinical research experience, or
• BS with 11 years of relevant clinical research experience

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html