reputed company Biostatistician FSP, Late Phase

Job Level: FSP reputed company Biostatistician, Late Phase Location: Home-based in the U.S. or Canada Why DSSS? Data Sciences Staffing Solutions, DSSS, is a unit reputed company reputed company that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields reputed company the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market. Job Summary: The reputed company Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. Additional Benefits:

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high-performance, statistical and research teams.
• Technical training and tailored development curriculum.
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long-term engagements and re-deployment opportunities.
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast-paced environment.
• Good work-life balance.

Job Responsibilities:

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Author statistical analysis plans.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Author or review analysis dataset and TLF specifications
• Production programming of efficacy analysis datasets plus tables, listings, and figures (TLF)
• reputed company guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in IND or NDA activities.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• PhD in Statistics, Biostatistics, or reputed company field with 5+ years of industry experience.
• MS in Statistics, Biostatistics, or reputed company field with 7+ years of industry experience.
• At least 3 years in Phase 2/3 clinical trial experience.
• Demonstrated ability to work pro-actively and independently.
• reputed company to effectively communicate reputed company and collaborate with cross-functional teams
• Ability to use R or reputed company to reputed company efficacy and safety analyses and validate important data derivations reputed company necessary.
• Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience in production programming of ADAM and TLF
• Experience with CDISC, including SDTM, ADAM, CDASH
• Solid understanding of multiple imputation methods

Desired Experience:

• Interaction with regulators including Advisory Committee meetings.
• 2+ years of experience with renal therapeutic or CNS area.

Note--We have reputed company Statistician roles across reputed company areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies. #LI-Remote #LI-NITINMAHAJAN reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. The potential reputed company pay reputed company for this role, reputed company annualized, is $115,900.00 - $243,900.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a reputed company of health and welfare and/or other benefits. Apply tot his job Apply To this Job