Sr Biostatistician
Posted 7 days ago by 1752830858
Negotiable
Outside
Remote
USA
Summary: The Sr Biostatistician role involves leveraging statistical expertise to design and analyze clinical trials and contribute to the clinical development plan of compounds. The position requires collaboration with program partners and stakeholders to ensure statistical deliverables are met, while adhering to company guidelines and regulatory requirements. The candidate will report to a franchise team leader within the Biostatistics and Statistical Modelling organization. A master's or doctorate degree in Statistics or a related field, along with significant experience in biostatistics, is essential for this role.
Key Responsibilities:
- Contribute statistical expertise to the design and analysis of clinical trials or clinical development plans.
- Collaborate with program partners and stakeholders to deliver statistical deliverables for clinical trials.
- Report to a franchise team leader within the Biostatistics and Statistical Modelling organization.
- Carry out functional responsibilities in accordance with company guidelines and regulatory requirements.
Key Skills:
- Master's or doctorate (Ph.D.) degree in Statistics or related field.
- Minimum of 5 years experience in biostatistics, including doctoral research.
- Expertise in drug development and advanced knowledge of biostatistics.
- Proficiency in statistical software (SAS and/or R).
- Ability to explain complex statistical concepts in English.
- Team-player with the ability to work autonomously.
- Experience with eCRT and Define knowledge.
- Project lead abilities and experience managing cross-functional teams.
- Preferable experience in Immunology and exposure to regulatory work.
- Proactive communication skills.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Title: Sr Biostatistician
Location: 100% Remote
Duration: Long term
Job Description
Contribute with your statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program.
Will closely collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials and contribute to HA submissions
Will report to a franchise team leader, within the Biostatistics and Statistical Modelling organisation
Will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
Education and Experience:
You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 5 years experience (which may include doctoral research in field of biostatistics) (Master is a required qualification)
You have expertise in drug development, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials
You are proficient in statistical software (SAS and/or R);
You are able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
You can clearly explain complex statistical concepts in written and spoken English
You are a team-player with focused attitude
You are able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast growing biotech company with challenging timelines
Knowledge, Skills and Abilities:
eCRT and Define knowledge
Proactive in nature
Project Lead abilities experience of working with cross functional teams and managing
TA experience is preferable ( Immunology)
Exposure to regulatory related work
Exposure to latest Stat models and design approaches will be preferred
Proactive communication