Loading...

Sr. Statistician

Location: 

Winnipeg, MB, CA, R3T 5Y3


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Sr. Statistician is responsible for providing statistical support for clinical projects. May serve as the lead study statistician and contributes to the design, conduct, and reporting of clinical trials, with the support of a senior statistical reviewer. Works collaboratively with clinical development functions such as clinical research, data management, statistical programming, and clinical operations to ensure that overall project objectives and timelines are met.


ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
•    Serves as study statistician under the supervision of a senior statistician, contributes to study design and protocol development (including sample size calculations), authors Statistical Analysis Plan including mock tables, listings, and figures (TLFs).
•    Supports the data management team in reviewing the study database design and other aspects of data collection and review.
•    Participates in clinical study team meetings, provides support as needed data review and cleaning, study monitoring committee meetings, and database lock.
•    Reviews the final data results (TLFs), contributes to the statistical and results sections of clinical study reports.
•    Carries out statistical analysis and prepares reports of data from clinical and pre-clinical studies as needed.
•    Collaborates with other Clinical Development staff on posters and manuscripts for associated clinical study work.
•    Provides statistical consultation and analyses as required to departments outside Clinical Development. 
•    Contributes to the development and maintenance of reporting standards, tools, and any other statistical applications as appropriate.
•    Supports the development of biostatistics SOPs and standard processes.
•    Updates skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise and biological/therapeutic area knowledge.

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 equivalent quantitative field.
•    For Master level, at least 4 years of relevant experience as biostatistician in a pharmaceutical, biotech, CRO or other clinical research setting.
•    Knowledge of statistical computing software including SAS or R. Experience with other software such as JMP, and nQuery a plus.
•    Solid knowledge in statistical methodology and applications including linear and logistic regressions, survival analysis, and clinical trial designs.
•    Experience with early phase clinical trials, vaccine and/or biologics development is a plus
•    Working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
•    Hands-on experience and basic knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define. 
•    Experience with writing statistical analysis plans, mock tables and specifications to meet regulatory and company standards.
•    Good organizational, analytical and problem-solving skills
•    Good written, verbal, and interpersonal communication skills.
•    Ability to work as part of a team. 
•    Increased responsibility matrix management, and mentorship will be added as expertise and ability are demonstrated.
•    Moderate independence on study design and conduct, with oversight, for basic biostatistical tasks is expected.  
 

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 Privacy Policy .
 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.