Negotiable
Outside
Remote
USA
Summary: The Senior Biostatistician will leverage statistical expertise to design and analyze clinical trials, collaborating closely with program partners to meet statistical deliverables and contribute to health authority submissions. Reporting to a franchise team leader, this role requires adherence to company guidelines and regulatory requirements while managing multiple clinical trials. The ideal candidate will possess a strong background in biostatistics and drug development, with proficiency in statistical software. This position is remote and classified as outside IR35.
Key Responsibilities:
- 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.
Key Skills:
- You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 5+ years of 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.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Role:
- 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 of 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