Principal Biostatistician FSP, Late Phase
Durham, United States of America | Full time | Home-based | R1460510 Job Level: FSP Principal 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 Principal 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.
- Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Author statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
- Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
- Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures.
- Interpret study results and review reports of study results for accuracy.
- Support exploratory analyses.
- Participate in pre-IND or NDA activities.
- Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- PhD in Statistics, Biostatistics, or reputed company field with 5+ years 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 his/her reputed company and to manage programmers in a constructive manner.
- 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 with CDISC, including SDTM, ADAM, CDASH
Desired Experience:
- Interaction with regulators including Advisory Committee meetings.
- 2+ years of experience with renal therapeutic area.
#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 outcomes 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 The potential reputed company pay range 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 range of health and welfare and/or other benefits. Apply tot his job Apply To this Job