Associate Director, Biostatistics FSP

Cytel; Helena (MT); Vor Ort; USD 140.000 - 200.000; Vollzeit

Zusammenfassung

Cytel is seeking an Associate Director of Biostatistics to support or lead clinical trials for drug development within an FSP framework. You will contribute to study concepts, SAPs, protocols, and regulatory documents, while providing expert biostatistical input and oversight of external resources.

The role emphasizes advanced statistical methods, machine learning and collaboration across departments to drive efficiency and innovation in statistical analysis.

Qualifikationen

• Master’s degree in Statistics with 7+ years in biotech/pharma.
• PhD preferred; strong statistical methods background.
• Proficient in R, SAS, Python; regulatory submissions knowledge.
• Experience with CDISC, SDTM and ADaM standards.

Aufgaben

• Support statistical strategy for drug programs and study SAPs.
• Oversee biostatistics deliverables produced by external resources.
• Contribute to protocols, CSRs, and scientific presentations.
• Review randomization procedures and randomization lists.
• Review CRFs and data management plans for statistical needs.
• Oversee outsourced CRO activities for timely quality.
• Develop innovative statistical tools and cross-functional initiatives.

Kenntnisse

Statistical analysis

R

SAS

Python

Regulatory knowledge

Vendor management

Machine learning

Communication skills

Ausbildung

Master's degree in Statistics

PhD preferred

Tools

R

SAS

Python

CDISC SDTM ADaM

Jobbeschreibung

Who Are You?

As an Associate Director of Biostatistics, you will be dedicated to one of our FSP clients, working as an extension of their staff to support or lead clinical trials for drug development, with the opportunity to leverage your experience and utilize advanced statistical methods in their Statistics group.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our FSP clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

Our Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

Your responsibilities will include:

• Support statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.

• Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by external resources.

• Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.

• Review the randomization procedures and oversight of the production of randomization lists.

• Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.

• Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.

• Produce innovative tools and methodologies for statistical analysis through literature review.

• Participate in the development of department strategies and cross functional initiatives on standards, infrastructure, and processes.

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• Master’s degree in Statistics or a related field, with 7+ years of experience in statistical analysis within the biotech/pharmaceutical industry. PhD preferred.

• Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs. Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.

• Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.

• Strong statistical programming skills (R, SAS, Python).

• Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications.

• Strong vendor management experience.

• Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.

• Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.

• Demonstrated ability to work independently, take ownership and be accountable for study and program-level statistical activities and deliverables

Cytel Inc. is an Equal Employment / Affidative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.