This role is on site (5 days a week) and required candidates to live in NE/IA.

Streck provides:

A challenging, safe and rewarding work environment
No night or weekend shifts
Excellent work life balance
Affordable, high-quality apartments for employees
Market competitive pay
Comprehensive and inclusive benefits
Great team environment
On and off campus career development opportunities

The Biostatistical Analyst is primarily responsible for applying statistical methods to support clinical research, new assay methods, design, validation, development and delivery of IVD devices. This role will collaborate closely with R&D, Regulatory, Quality Control and Strategic Accounts. Projects under this role will require knowledge and application of current statistical methodologies and associated software.

Essential Duties and Functions:

1. Analyze and interpret IVD’s analytical and clinical studies for submissions to regulatory bodies (e.g., FDA).
2. Support technical writing of documentation relevant to internal audits.
3. Write reports, and technical documents summarizing findings related to projects as requested by management.
4. Attend and actively participate in all applicable divisions, department, and team meetings.
5. Attend meetings with clients, trade shows, scientific conferences and industry functions as requested by management.
6. Provide statistical training for non-statistical groups within R&D and/or QC.
7. Stay abreast of new developments in statistics, industry developments, and regulatory guidance through literature review and attendance at workshops and professional meetings.
8. Develops the responses to statistical issues arising in regulatory, quality and compliance, or other legal settings; prepares protocols, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, local Institutional Review Board, and other health authorities.
9. Basic understanding of FDA guidance documents, CLSI and ISO documents.

Position Requirements include

• Master’s degree in Biostatistics, Statistics, or related field.
• Minimum of 2 years of experience directly related to designing, analyzing, and reporting.
• Excellent communication skills (written and verbal).
• Strong ability to interact with other scientists and stakeholders across various disciplines.
• Ability to distill complex concepts into terms easy to grasp for a general audience.
• Strong fluency with R, SAS and/or Python software.

Technical Competencies:

• Proficiency with SAS/Base, SAS Macro, R or MiniTab.
• Knowledge of general clinical laboratory operations and procedures.
• Basic knowledge of FDA Design Control and QSR compliance requirements.
• Basic knowledge of FDA/EU submission process and guidelines for IVD/IVDR submissions.
• Basic knowledge of CLSI guidelines for analytical and clinical studies of medical devices.
• Ability to collaborate with various departments within the organization.
• Ability to design experiments that test a clear and concise hypothesis.
• Ability to present technical material in a written format.
• Ability to prioritize work to meet scheduled and or project deadlines.
• Ability to communicate effectively with external customers and colleagues of differing backgrounds both in scientific and business settings.
• Ability to think creatively with strong problem solving and planning experience.
• Strong listening skills are necessary.
• Strong analytical, data analysis and interpretation skills.

Work Environment/Travel Demands:

The work environment is a climate-controlled biological/chemical laboratory. Occasional short durations to cold temperatures inside walk-in coolers. Ability to wear required laboratory clean room clothing (laboratory coats, hair bonnets, and beard covers (as applicable) and other safety/protective equipment (masks, gloves, and/or face shields for example) for up to two and a half hours consecutively. Travel demands for this position are estimated up to 5%. If travel is required, this travel may include customer visits, events/trade shows, and completion of presentations primarily throughout Domestic US or International regions. Employees must comply with all travel recommendations regarding “safe travel” according to company policies and guidelines, and all federal, state, local, and international orders.

Physical and Mental Demands:

Sedentary work exerting up to 10 pounds of force occasionally, and/or up to 5 pounds of force frequently, and/or up to 5 pounds of force constantly to move objects. This also includes standing for up to two and a half hours consecutively, walking, pushing, pulling, lifting, reaching, stooping, fingering, and grasping. Expressing and receiving detailed information through written and oral communication. Also has an ability to make sound, appropriate, and prompt decisions within the guidelines of the role.

**The work environment characteristics and physical demands stated in their respective sections are representative of those necessary to perform the essential functions of the job. Reasonable accommodations will be reviewed and considered. If approved, accommodation may be made to enable individuals with disabilities to perform the essential functions of their assigned role.

The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Visit www.streckcareers.com to learn more about Streck and apply for this opportunity.

Streck is an Equal Opportunity/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.