Contract Principal Biostatistician

We are looking for a Principal Biostatistician to work 40 hours a week on a 6 month contract at a Southern California biotech. 

Position Summary
This position is responsible to be a member of a cross-functional clinical development team and contributes to clinical trial design, study protocol development, statistical analysis planning, interpretation of results, preparation of regulatory submissions and publications. You will work collaboratively with data management, statistical programming, external partners, medical director(s), clinical scientists, clinical study managers, project managers, PK scientists, and other members of the study team.

Essential Functions

• Leads the development and execution of all statistical aspects for clinical trials, including contribution to clinical trial design, statistical analysis planning, study results presentation and interpretation, clinical study report, regulatory documents (IND submissions, briefing package, DSURs, etc.), regulatory submissions, and publications. 

• Serve as lead statistician on multiple studies/projects across different therapeutic areas.

• Accountable for ensuring quality in planning, design and execution of assignments associated with the assigned projects.

• Contributes to clinical study designs and strategic discussions around the clinical development plan.

• Performs statistical simulation and / or power calculations to determine the appropriate sample size for a clinical trial.

• Authors statistical and sample size sections in developing clinical study protocols.

• Collaborates with Data Management and other members of the study team on the design or modification of the eCRFs.

• Represents Biostatistics function in project and study team meetings with cross functional team members.

• Provides vendor management and oversight and ensure quality in CRO deliverables such as statistical analysis plan and TFLs.

• Participates in meetings with regulatory authorities (FDA, EMA, etc.) as necessary.

• Contributes to scientific presentations and manuscripts for publications, summarizing data collected in clinical trials, or analyzing external data.

• Involved in Data Science’s standard operating process development. 

• Utilizes project management principles both upstream and downstream to ensure study deliverables are accomplished according to the plan.

Qualifications
Education & Experience

• Ph.D. in statistics, biostatistics, mathematics, or related quantitative field with 7 or more years of experience in biopharmaceutical /CROs; or MS in statistics with 10 or more years of experience in biopharmaceutical/ CROs. 

• Understanding of ICH GCP and good knowledge of industry practices and standards as related to biostatistics and clinical trials.

• Extensive knowledge of statistical methodology and data analytic methods used in clinical trials.

• Knowledge or experience in adaptive designs or innovative statistical methodology in the clinical, and regulatory environments.

• Statistical computing and simulation skills with proficiency in one or more programming languages such SAS and R.

• Experience in Bayesian methodologies and multiple imputations

• Experience with CDISC standards, including SDTM, ADaM, and CDASH standards. 

• Excellent verbal and written communications skills, including the ability to clearly articulate statistical concepts to non-statisticians. 

• Ability to engage effectively as a team player within a fast-paced working environment.
• Ability to be flexible and adapt quickly to the changing needs of the organization

Contact:???????
If you are interested in the position please apply via LinkedIn or email Dominick.poletti@meetlifesciences.com