Director, Biostatistics

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 impact, do the best work of your career, and grow a lot, both professionally and personally, come join reputed company. Position reputed company: ultracurious – Apply your biggest reputed company in courageous ways The Director of Biostatistics acts as program statistical reputed company; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data reputed company assurance.  The Director of Biostatistics contributes to identifying, developing, and implementing departmental standards, applications, processes, and training. Provides reputed company support to the project teams on reputed company statistical reputed company according to the project strategies and is responsible for addressing reputed company administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may reputed company key deliverables at the project level.  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 in product / indication level tasks including regulatory interactions and filing, and ensure statistical reputed company; contribute strategically to the supporting reputed company from statistics perspective  Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics reputed company in the protocol, reputed company and DMC charter; Create/review study randomization files; reputed company TFL reputed company and specification Review CRFs and other study documentations; reputed company participation in study reputed company meetings  Works collaboratively reputed company biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting  Ensure statistical reputed company of deliverables; reputed company statistically reputed company scientific methodology input to meet project objectives and regulatory statistical and data requirements  Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results  Contribute to developing standards and research in advanced statistical methodologies  Author/review regulatory documents or scientific publications  Mentor junior team members  Requirements: PhD in Statistics or Biostatistics with a minimum of 8 years (min 11 years for Masters) of post-graduate experience in the clinical trials setting in the pharmaceutical industry  reputed company in NDA / BLA / MAA activities as a key contributor from statistics perspective and reputed company involvement in regulatory interaction  reputed company as product reputed company statistician and contributing to reputed company discussion in cross functional settings; reputed company in managing multiple products and studies and being reputed company to prioritize  reputed company in study level work including authoring reputed company and TFL specification  Familiar with ICH reputed company, FDA / EMA / other regulatory authority guidance  Solid understanding of mathematical and statistical principles; Experience in statistical reputed company analyzing longitudinal data is preferred  Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company reputed company  Familiar with reputed company and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies  #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 $220,700—$272,700 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 strictly 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 To This Job