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Associate Director/Sr. Manager, Statistical Programming

Company: Moderna Therapeutics
Location: Cambridge
Posted on: February 17, 2021

Job Description:

Associate Director/Sr. Manager, Statistical Programming Cambridge, Massachusetts Clinical Development 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 Senior Manager / Associate Director of Statistical Programming will be responsible for statistical programming deliverables across Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients Here's What You'll Do:

  • Oversee CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
  • Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
  • Provide technical leadership in SAS programs and applications to report clinical trial data and for submissions of data in CDISC format
  • Generate SDTM domains, ADaM datasets, and define.xml files
  • Generate tables, figures, and listings as described in statistical analysis plans
  • Develop quality control processes for SAS programing and execute for regulatory reporting, publications, and press releases
  • Provide statistical programming support to exploratory analyses both internally and in response to regulatory agencies' ad-hoc requests
  • Participate in the development of CRFs, edit check specifications, and data validation plans
  • Provide review and/or author data transfer specifications for external vendor data
  • Define and maintain data repository folder contents associated with statistical programming
  • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
  • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goals
  • Oversee statistical programming contractors and mentor junior team members Here's What You'll Bring to the Table:
    • MS or PhD (or equivalent degree) with 6+ years or BS with 8+ years of relevant work experience in Biotech, Pharma, Clinical Research Organizations, or other relevant organizations
    • Mastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
    • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
    • Experience working with CROs, vendors, and relationship management preferred.
    • Outstanding communication skills (verbal and written).
    • Ability to manage multiple projects in a fast-paced environment.
    • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.Here's What We'll Bring to the Table:
      • On-site subsidized cafeteria or 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
      • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
      • 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 and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays) About Moderna: In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .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. #LI-AK1- Posted 19 Days Ago Full time R3569 About Us Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Associate Director/Sr. Manager, Statistical Programming, Executive , Cambridge, Massachusetts

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