Director, Statistical Programming New United States - Remote

Company: Tbwa Chiat/Day Inc
Location: Boston
Posted on: November 18, 2024

Job Description:

Location: This position may be performed remotely with travel to the Boston area as needed.The OpportunityReporting to the Vice President, Data Sciences, the Director of Statistical Programming will provide technical, operational, and computational algorithmic input to the development of statistical programming deliverables within one or many clinical programs at Praxis. This person will work closely within Data Sciences and cross-functionally with the Clinical Development team, including Clinical Operations, Clinical Pharmacology, and Regulatory functions to implement clinical studies as part of a larger clinical development plan and to report and analyze clinical study data. This individual is also accountable for reviewing, approving, producing, and validating statistical programming deliverables.Primary Responsibilities

• Develop and maintain CDISC-compliant and submission-ready programs, SDTM, ADaM, tables, listings, and figures.
• Ensure accurate, statistically valid deliverables in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
• Work towards simultaneous achievement of major statistical programming deliverables and milestones for one or many clinical trials in collaboration with the clinical development team and other functions.
• Collaborate with data management and biostatistics to provide timely and accurate statistical programming deliverables.
• Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines.
• Provide input for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.
• Collaborate with Data Management and Biostatistics to build internal capabilities and develop standard processes for CDISC compliant data sets (SDTM and ADaM), performing formal tables, listing & figure production and QC in preparation for submission readiness.Qualifications and Key Success Factors
  • MS in Biostatistics, Statistics, Mathematics, Computer Sciences, Life Sciences, or equivalent with a minimum of 15 years of relevant experience.
  • Excellent SAS programming and analytical skills to develop programs for QC using SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS Macros. Ability to do simulations in a programming language such as SAS. Proficiency in R and/or Python is a plus.
  • Comprehensive experience mapping, developing, and validating data following the CDISC guidelines, specifically SDTM and ADaM. Fluency in Pinnacle 21 Enterprise Version.
  • Extensive experience with IND/NDA activities and regulatory interactions, including filing, ISS, and/or ISE experience. Knowledge of GCP/ICH guidelines for conducting clinical trials.
  • Pharmaceutical experience with clinical trials, including familiarity with the expectations of regulatory agencies, especially the FDA.
  • Effective communicator: able to explain the methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
  • Able to manage multiple projects and conflicting priorities, and to be flexible when priorities change.
  • Effective team player willing to go the extra distance to deliver results, meet/exceed deadlines, etc.Benefits
    • 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans.
    • Bonus program structured to pay on a quarterly basis.
    • 401k plan with 100% match up to 6% of employee's contribution (Traditional & Roth).
    • Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more.
    • Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit.
    • Eligibility for equity awards and Employee Stock Purchase Plan (15% discount).Salary$210,000 - $230,000 USDCompany OverviewPraxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.Diversity, Equity & InclusionGuided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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Keywords: Tbwa Chiat/Day Inc, Portland , Director, Statistical Programming New United States - Remote, Executive , Boston, Maine