FSP Principal Biostatistician, Safety

Job: FSP Principal Biostatistician, Safety

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 Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes.

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:

• Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials.
• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Participating in study design discussions, including protocol development
• Write the statistical sections of clinical trial protocols.
• Reviewing CRFs, data review guidelines, and reputed company study documentation to ensure statistical and safety considerations are appropriately addressed.
• Developing and reviewing statistical analysis plans and TFL templates.
• 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.
• Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
• reputed company exploratory safety analyses
• reputed company validation of analysis variables and statistical outputs
• Interpret study results and review reports of study results for accuracy.
• Present, communicate and interpret safety analyses to study teams
• Support exploratory analyses.
• Participate in pre-IND or NDA activities.

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 5 years of Phase 1, 2 and 3 clinical trial experience.
• Demonstrated ability to work pro-actively and independently.
• Able 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:

• Leading DSBM or DMC for biostatistics

#LI-Remote #LI-NITINMAHAJAN

reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare 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 qualified applicants will receive consideration for employment without regard to race, color, 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 discovered reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.