Senior Principal Statistical Programmer
We are a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. We are headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. Description:The Statistical Programming Group within the Department of Data Science is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.Essential Functionsâ?¢ Responsible for all statistical programming activities within a therapeutic project or equivalentâ?¢ Lead, manage, develop and support statistical programming teamâ?¢ Manage critical deadlines, demonstrate ability to problem solving, and ensure quality statistical programming deliverables will be completed within designated timeframe.â?¢ Serve as project leader on studies or tasks of greater complexityâ?¢ Attend multi-disciplinary team meetings, representing the statistical programming function.â?¢ Create or review and approve programming plans at study and project level.â?¢ Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)â?¢ Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agenciesâ?¢ Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agenciesâ?¢ Assist statisticians by suggesting algorithms to address novel analysis requestsâ?¢ Develop software validation procedures and test plans, as necessary.â?¢ Create and document archives of software, outputs, and analysis files.â?¢ Contribute to the creation and maintenance of department SOPs related to clinical data analysis.â?¢ Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.â?¢ Oversee work of internal contract programmers and external vendors.â?¢ Provide time and resource estimates for project planning.Minimum Requirementsâ?¢ Bachelorâ??s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Masterâ??s Degree preferredâ?¢ Minimum of 10 years of experience in developing software for clinical trials using the SAS system, with 3 or more years of supervising SAS programmers.â?¢ Skilled in programming with SAS. Knowledge of additional programming languages a plus.â?¢ Good knowledge of statistics and drug development processâ?¢ Experience as a lead programmer for NDAs/BLAsâ?¢ Experience overseeing the work of internal contractors and external vendors (CROs)â?¢ Experience in pharmacokinetics/pharmacodynamics modeling a plusâ?¢ Good knowledge with CDISC standards, including SDTM and ADaM modelsâ?¢ Solid verbal and written communication skills. We are an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.We are an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.FOR US-BASED CANDIDATES ONLY. We. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $144,000-$189,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate\'s qualifications, skills, and experience.We your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company\'s Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with us Long Term Equity Incentive Plan.The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.