Manager / Senior Manager, Statistical Programming

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
June 19 2019
Ref
R1688
Discipline
Life Sciences, Biology
Organization Type
Biotech
Manager / Senior Manager, Statistical Programming

The Role:

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager/Senior Manager of Statistical Programming will be providing leadership and hands-on support to multiple clinical study teams on all statistical programming matters across Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients.

Here's What You'll Do:

  • Lead one or more projects for all programming deliverables and milestones. Oversee CRO programming activities and ensuring compliance with SOPs to produce high quality and timely deliverables
  • Represent Statistical Programming in project teams and be the point-of-contact for programming effort. Responsibilities may include but not limited to:
    • Independently develop and validate technical programming specifications and programs, generate analysis datasets based on SDTM and ADaM standards, and produce SAP specific tables, listings, and figures/graphs.
    • Develop and execute programming quality control processes for regulatory reporting, publications, and press releases
    • Ensure effective filing of all statistical programming related study documentation following Moderna's SOPs
  • Work closely with the Biostatistics & Statistical Programming leadership in aspects of the management and development of the team. Activities may include:
    • Participate in the development and review of all the SOPs for the Statistical Programming group to ensure processes are implemented with 100% compliance.
    • Create and/or review programming plans and ensure proper resource allocation and prioritization.
  • Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Moderna to effectively address their needs for programming support.
  • Oversee statistical programming contractors and mentor junior team members


Here's What You'll Bring to the Table:
  • BS/BA/MA/MS or equivalent with 5+ years statistical programming experience in biotech / pharmaceutical companies or CROs.
  • 2+ years programming project management experience in biotech / pharmaceutical companies or CROs.
  • Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
  • Extensive experience and proven skills in use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles.
  • Working knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support electronic submissions in the eCTD format.
  • 3+ years vaccine or oncology or rare diseases experience is preferred
  • Strong verbal and written communication skills and proven ability to clearly and effectively present technical information.
  • Excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.
  • Advanced experience with:
    • Constructing technical programming specifications.
    • Good Clinical Practices.
    • Good Programming Practices.
    • 21CFR Part 11 Standards.
    • Integrated Summary Safety/Efficacy Analyses.
    • Safety data and Coding Dictionaries (MedDRA and WHODD).
    • Creating programming files required to support an electronic submission in the eCTD format.


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation, with an additional day added after each year of service 7 sick days per year, in addition to a discretionary winter shut down and 13 company paid holidays (includes 2 floating holidays)

Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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