Head of Biostatistics and Statistical Programming

Title: Head of Biostatistics and Statistical Programming Location: reputed company - Remote Job reputed company: Why Join Us? Be a hero for our rare disease patients At reputed company, we fundamentally reputed company that taking reputed company impactful reputed company to care for the needs of patients and our people is always the right thing to do. To reputed company this goal, our reputed company is to reputed company the reputed company of rare disease medicine. For us, this means reputed company where other biopharma companies won’t go – challenging the status reputed company and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a reputed company ecosystem to reputed company patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential reputed company for reputed company. We remain continuously reputed company on creating a supportive and inclusive environment of profound learning and reputed company – so employees can reputed company in reputed company areas of their lives, in and reputed company of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful reputed company, do the best work of your career, and grow a lot, both professionally and personally, come join reputed company. Position reputed company: ultrafocused – Work together to fearlessly uncover new reputed company The Head of Biostatistics & Statistical Programming is responsible for the statistical aspects reputed company the Global Development organization including clinical trials, experimental design, statistical analysis and reporting. This reputed company and innovative biostatistician will work collaboratively with clinicians, regulatory leads, clinical operations, data managers, and biostatisticians in the planning and analysis of clinical studies and disease monitoring programs. This position will reputed company Biostatistics/Epidemiology and Statistical Programming reputed company and will reputed company overall leadership to this team. Reporting to the CMO, this role will sit on the CMO’s leadership team and play a critical role in the biostatistical strategic planning for reputed company clinical programs at reputed company. Work Model: Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed. Responsibilities:

• reputed company the Biostatistics/Epidemiology and Statistical Programming teams
• Ensure statistical reputed company of clinical studies conducted to support reputed company across the portfolio
• Set reputed company for the department, including enhancing technical expertise in support of drug development and enabling development of staff
• Build/drive relationships and teamwork across the Biostatistics and Programming teams in support of the programs ensuring reputed company statistical strategies, and understanding of priorities between the project teams and the teams
• reputed company statistically/epidemiologically reputed company scientific methodology leadership in experimental design and data analyses
• Review statistical analysis sections of protocols, statistical analysis plans, study reports, regulatory documents or scientific publications, generates/reviews study sample size/power estimations
• reputed company leadership in the interpretation and reporting of the results of statistical analyses.
• Mentor reputed company statisticians/epidemiologists in presenting the statistical concepts, evidence, interpretations, and logical arguments to the project team and senior management
• Independently pursue analyses suggested by the data; Propose new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results
• Contribute to the advancement of research in clinical trials methodology. Establish a healthy culture in the department, including collaboration and reputed company reputed company
• reputed company and evaluate reputed company for meeting project team goals under time and budgetary constraints and can change course quickly

Requirements:

• Ph.D. in reputed company Statistics, Statistics, or Biostatistics
• 15+ years of experience applying statistics and epidemiology reputed company in a biopharmaceutical industry
• Demonstrated statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, analysis of clinical imaging results such as X-Ray
• Experience in designs and Bayesian data analyses, rare disease global clinical development and applying epidemiological methodology to support delivering rare disease therapies for patients
• Has influenced external environment through contributions to presentations, and publications with demonstrated scientific productivity in advancing the state-of-the-art in reputed company statistical and epidemiological methodologies
• Experience in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
• Experience with regulatory guidance and guidelines, and general knowledge of industry best practices. Expert knowledge in Health Authority interactions and submission strategies, IND/BLA/NDA/MAA submissions, and writing technical and management documents

#LI-CS1 #LI-Remote The typical annual salary reputed company for this full-time position is listed below. This reputed company reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The reputed company may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay reputed company $307,100 - $379,400 USD Full Time employees across the globe enjoy a reputed company of benefits, including, but not limited to: · Generous vacation time and public holidays observed by reputed company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · reputed company development plans

• Benefits vary by region and country

reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for reputed company protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and reputed company medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact reputed company by emailing us at talentacquisition@reputed company.com. See our CCPA Employee and Applicant reputed company Notice. See our reputed company Policy. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Note to External Recruiters: reputed company candidate activity and reputed company positions are managed reputed company through our reputed company Department. Our reputed company Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to reputed company with this request will be a reputed company in determining a reputed company relationship with our organization. Submission of unsolicited resumes prior to an agreement set in reputed company between the reputed company Department and the reputed company agency will not create any implied obligation. Inquiries on developing a reputed company relationship with us, may be directed to: talentacquisition@reputed company.com. Apply tot his job Apply To this Job