Actalent
Overview
We are a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases. Our mission is to improve the daily lives of patients living with devastating rare diseases by developing innovative libraries of genetic regulators and other enabling technologies. Responsibilities
Lead and execute statistical programming activities to support early-phase clinical trials and regulatory submissions for our gene therapy programs. Conduct regulatory submissions using R, ensuring the development, validation, and maintenance of programs for creating SDTM and ADaM datasets and TFLs in compliance with CDISC standards. Prepare documentation for clinical trials and regulatory filings, including TFL shells and SDTM/ADaM specifications. Participate in the development of standard operating procedures and working instructions. Contribute to the development and implementation of AI/ML solutions, including automated clinical trial monitoring and reporting. Collaborate cross-functionally across multiple drugs and indications with Biostatistics, Data Sciences, Medical Writing, Regulatory Publishing, and Clinical Operations to ensure data deliverables meet regulatory timelines and internal quality standards. Essential Skills
Proficiency with AWS and Posit. Strong knowledge of data engineering tools such as Python, R, and SQL for data processing. Familiarity with Git, Docker, and SAS. Understanding of the drug development process and associated regulatory requirements. Exposure to healthcare data standards (e.g., CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Exposure to big data technologies and handling. Knowledge of machine learning operations and model deployment. Additional Skills & Qualifications
Bachelor’s degree in statistics, mathematics, computer science, or equivalent field. Experience with SAS and R programming in a pharmaceutical or biotech setting. Knowledge in CDISC, including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as industry standards for electronic submission of data to regulatory agencies. Work Environment
This position is 100% remote, and you will be working during Eastern Standard Time (EST) hours. Job Type & Location
This is a Contract to Hire position based out of Boston, Massachusetts. Pay and Benefits
The pay range for this position is $79.00 - $98.56/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type
This is a fully remote position. Application Deadline
This position is anticipated to close on Sep 16, 2025. About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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We are a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases. Our mission is to improve the daily lives of patients living with devastating rare diseases by developing innovative libraries of genetic regulators and other enabling technologies. Responsibilities
Lead and execute statistical programming activities to support early-phase clinical trials and regulatory submissions for our gene therapy programs. Conduct regulatory submissions using R, ensuring the development, validation, and maintenance of programs for creating SDTM and ADaM datasets and TFLs in compliance with CDISC standards. Prepare documentation for clinical trials and regulatory filings, including TFL shells and SDTM/ADaM specifications. Participate in the development of standard operating procedures and working instructions. Contribute to the development and implementation of AI/ML solutions, including automated clinical trial monitoring and reporting. Collaborate cross-functionally across multiple drugs and indications with Biostatistics, Data Sciences, Medical Writing, Regulatory Publishing, and Clinical Operations to ensure data deliverables meet regulatory timelines and internal quality standards. Essential Skills
Proficiency with AWS and Posit. Strong knowledge of data engineering tools such as Python, R, and SQL for data processing. Familiarity with Git, Docker, and SAS. Understanding of the drug development process and associated regulatory requirements. Exposure to healthcare data standards (e.g., CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Exposure to big data technologies and handling. Knowledge of machine learning operations and model deployment. Additional Skills & Qualifications
Bachelor’s degree in statistics, mathematics, computer science, or equivalent field. Experience with SAS and R programming in a pharmaceutical or biotech setting. Knowledge in CDISC, including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as industry standards for electronic submission of data to regulatory agencies. Work Environment
This position is 100% remote, and you will be working during Eastern Standard Time (EST) hours. Job Type & Location
This is a Contract to Hire position based out of Boston, Massachusetts. Pay and Benefits
The pay range for this position is $79.00 - $98.56/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type
This is a fully remote position. Application Deadline
This position is anticipated to close on Sep 16, 2025. About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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