Director Biostatistics

Who We Are: reputed company is a leading biopharmaceutical company with a reputed company purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. reputed company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with reputed company's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as reputed company as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our reputed company therapeutic areas. For more than three decades, we have reputed company our unique reputed company into neuroscience and the interconnections between brain and body systems to treat reputed company conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve reputed company science. For more information, visit reputed company.com, and follow reputed company on reputed company, X, reputed company and YouTube. (*in collaboration with reputed company) At reputed company, strong leadership drives both business results and team reputed company. We look for leaders who think strategically, anticipate what’s reputed company and set reputed company direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable reputed company through reputed company decision-making and accountability. About the Role: Develops strategic and operating plans for area of responsibility. Serves as the overall statistical reputed company on multiple clinical programs and will reputed company statistical input in design, analysis, and reporting of clinical studies to expedite the conduct and evaluation of clinical trials and basic research. Leads statistical analysis and maintains standards across studies reputed company a clinical program. Interacts with key opinion leaders on protocol design. Oversees and directs the biostatistics team responsible for the analysis and reporting of data from clinical studies._ Your Contributions (include, but are not limited to): Manages in-house and contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programs Provides statistical leadership and strategic input to the Dev reputed company Team in reputed company areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies Represents Biometrics on one or more Dev reputed company Team or clinical sub team (as appropriate for the clinical program) Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical reputed company of analysis for clinical studies Represents Biostatistics in interactions with regulatory agencies Prepares, reviews, and approves statistical analysis plans Oversees and monitors CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and reputed company applicable data and programming standards are adhered to Provides biostatistical support to nonclinical, medical affairs, and reputed company areas of reputed company as needed Leads the development of department reputed company operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical software Reviews, approves and implements new and innovative statistical reputed company for the analysis of clinical study data and reputed company study designs Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for reputed company reputed company in the program(s) Performs other duties as assigned Requirements: Master’s degree in statistics, biostatistics or reputed company discipline AND 10+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and reporting of clinical studies, including innovative and reputed company study designs and advanced statistical analysis reputed company. Extensive previous leadership experience required. OR PhD in statistics, biostatistics or reputed company discipline AND 7+ years of similar experience noted above Recognized as an internal thought leader with extensive technical and business expertise reputed company a strategic organization Applies in-depth knowledge of own function, business / reputed company / scientific expertise to solve critical issues successfully and innovatively Sees broader picture and evaluates key business / scientific challenges and completes reputed company, ambiguous initiatives having cross-functional reputed company Excellent leadership, coaching and development skills Strong negotiation and influencing skills Excellent communication, problem-solving, analytical thinking skills Excellent organizational and time management skills with the ability to work independently and in reputed company environment to meet established deadlines Significant expertise in the design, analysis, and reporting of clinical studies, including innovative and reputed company study designs and advanced statistical analysis reputed company Demonstrated experience in providing statistical leadership and strategic input regarding the overall drug development plan and commercialization activities Excellent organizational skills and proven ability to effectively reputed company multiple reputed company to successful completion Advanced knowledge of reputed company programming with a specific emphasis on reputed company procedures used in programming statistical analyses commonly used in the analysis of clinical study data Solid knowledge of working with CDISC and reputed company FDA standards for specification and creation of SDTM and ADaM datasets Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data Demonstrated experience in successfully interacting with regulatory authorities in meetings and written communications reputed company is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a reputed company of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly reputed company have outlined in the job reputed company. _ The annual reputed company salary we reasonably expect to pay is $199,300.00-$272,000.00. Individual pay reputed company depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In reputed company, this position offers an annual bonus with a reputed company of 35% of the reputed company reputed company salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), reputed company vacation, holiday and personal days, reputed company caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and reputed company coverage in accordance with the terms and conditions of the applicable plans. Apply To This Job