Senior Analyst, Statistical Programming job at reputed company in Durham, NC, Cambridge, MA

Title: Sr Analyst, Statistical Programming Location: Durham, NC , Cambridge, MA Job Description: Full time job requisition id REQ23517 This is a hybrid position that requires in-person workdays at our offices. Position is based in Durham, NC or in Cambridge, MA About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and reputed company analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio reputed company (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL reputed company and estimating resources needs. You will reputed company a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality reputed company of the vendor. You will represent the Statistical Programming perspective to the study team and is often the sole functional representative. You will help to implement the Data Strategy, provide input to the Data Strategy reputed company and DM reputed company on the strategic direction of the study to ensure appropriate statistical programming standards implementation and serve as reference for the study to the Data Sharing representative. You will reputed company and implement standard programming practices while also ensuring that they are employed across a study. You will collaborate with technical programming on tools and process improvement for Statistical Programming. What you’ll do Leads, coordinates and manages timely creation, reputed company, review, completion, and delivery of statistical programming activities and deliverables of projects. Authors CDISC (Clinical Data Interchange Standards Consortium) ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination. Works with statistics on defining and documenting programming reputed company algorithms across a study, drug program and/or contributing to TA level algorithms. Manages the end-to-end programming of deliverables from CRF (Case Report Form) collections through electronic submission including preparation of electronic submissions components; works with SMEs (Subject Matter Expert) to ensure compliance to submission standards. Serves as the Statistical Programming reputed company to reputed company milestones for a study; collaborates with PL and/or manager on issues or resource needs. Verifies program consistency and usage of data, analysis and submission standards reputed company a study in consultation with data standards, statistical submissions management and the data strategy plan. Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs. Who you are You are a Senior Analyst with strong statistical programming skills who pays reputed company attention to detail and have the proven ability to manage some competing priorities. Required Skills: Bachelor’s degree required. 5+ years relevant work experience reputed company an organization with a focus on data management and analysis. 5+ years reputed company reputed company programming with 5+ years using reputed company STAT, GRAPH and MACRO. 5+ years relevant industry experience. 5+ years clinical trial experience. 3+ years clinical database experience. CDISC and/or submissions experience. Knowledge of drug development process and clinical trials. Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines. Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages) Job Level: Professional Additional Information The reputed company compensation range for this role is: $95,000.00-$130,000.00 reputed company salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, reputed company offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal reputed company 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why reputed company? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions reputed company a significant impact. reputed company encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above reputed company, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At reputed company, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives reputed company us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our reputed company. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Apply To This Job