Lead Statistician

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

REMOTE OPPORTUNITY - U.S. or Canada

JOB SUMMARY

* Provides statistical support for complex studies and/or all studies of a product development project.

* Leads study design, data analysis, and interpretation of results with a high degree of independence and participates in interactions of funding and regulatory agencies including authoring regulatory responses.

* Serves as the senior statistical reviewer in clinical studies to provide statistical oversight according to SOPs.

* Contributes to process improvement of the biostatistics function and ensures compliance at every level.

* Provides leadership in cross-functional teams and mentors junior staff members.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

* Reviews programs and outputs (TFLs) for analysis and reporting from clinical and pre-clinical studies and project-level documents (DSUR, ISS, ISE, etc).

* As lead therapeutic area or project statistician, supports Biostatistics and Data Sciences teams maintaining consistency across a program in their study documents and acts as a liaison with Clinical Operations/Medical.

* Develops Statistical Analysis Plans for studies and regulatory filings.

* Collaborates with Clinical Development teams to develop clinical development plans, protocol designs, and sample size calculations.

* Actively participates in clinical study team meetings. Leads departmental study subteams.

* Prepares and reviews statistical and results sections of clinical study reports and aids in authoring project regulatory filing documents.

* Supports the design of PK, clinical, and pre-clinical studies.

* Participates in the evaluation of and response to government RFPs, BAAs, RFIs, and RFAs in support of new and existing products.

* Provides statistical guidance, oversees study conduct, and works with CROs to ensure successful completion of studies.

* Authors, with other Clinical Development staff, posters and manuscripts for associated clinical study work.

* Provides statistical consultation and analyses as required to departments outside Clinical Development.

* Serves as study and project lead biostatistician for late-phase programs.

* Serves as SME for the Pharmacovigilance Safety Review Team.

* Leads the biostatistics effort by working collaboratively with Clinical Operations and Clinical Development, Statistical Programming, Data Management, Regulatory, and Project Management staff to meet project deliverables and timelines.

* Provides input into project resource forecasts and timelines.

* Leads interactions with Statistical Programming, Data Management, and other functions for the development and maintenance of reporting standards, data review and reporting tools, and any other statistical applications as appropriate.

* Assumes increased responsibility for development of biostatistics SOPs and standard processes.

* Hones leadership skills and stays up to date with evolving industry standards, statistical concepts, regulatory expertise, and biological/therapeutic area knowledge.

* Mentors Biostatistics, Data Management, and Statistical Programming staff on processes and statistical needs as relevant to their roles.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

* Advanced degree (Master or PhD) in biostatistics, statistics, mathematics, or related quantitative field.

* MS: At least 12 years of relevant biostatistics experience in a pharmaceutical, biotech, CRO, or other clinical research setting.

* PhD: At least 10 years of relevant biostatistics experience in a pharmaceutical, biotech, CRO, or other clinical research setting.

* Knowledge of statistical computing software including SAS, SQL, Microsoft Excel, Access, and Word. Experience with other software such as R, JMP, and nQuery a plus.

* Experience with all phases of clinical trials.

* Expert knowledge of GCP, ICH, FDA/EMA, and HIPAA regulations and guidelines.

* Experience with vaccine and/or biologics development.

* Experience with regulatory agency interactions.

* Hands-on and solid knowledge of CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define.

* Excellent organizational, analytical, and problem-solving skills, including the ability to prioritize tasks.

* Extensive experience with performing regression analysis, ANOVA, sampling techniques, categorical data analysis, statistical process control, experimental design, and exploratory data analysis.

* Demonstrated ability to write statistical analysis plans, mock tables, and specifications to meet regulatory and company standards.

* Ability to effectively oversee work of outsourcing partner.

* Excellent written, verbal, and interpersonal communication skills. Ability to communicate complex statistical concepts to non-statistical colleagues.

* Ability to lead internal Biostatistics and Data Sciences project teams.

* Responsibility for matrix management and mentorship within Biostatistics and Data Sciences teams.

* Independence for project oversight of biostatistics, programming and validation, and data management tasks is expected.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.