Biostatistician Iii

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer

Responsibilities:

• Under the supervision of the Biostats Sr. Manager, the Biostats associate will provide biostatistical support to product development projects (IVD assays, instruments and software) which includes evaluation of product design verification and design validation. Associate will write statistical analysis plans for analytical and clinical validation studies and provide consultation and mentorship on statistical issues to R&D, Clinical Affairs, Regulatory Affairs, and Operations teams.

• Individual will conduct data reviews, write reports, and present analyses and their interpretations to members of the R&D group. Associate will practice Design of Experiments from a statistical view-point (DOE), perform data analysis and provide interpretation. Other activities include building sample size determinations, performing calculations of clinical accuracy (PPA, NPA, PPV, NPV) and provide additional analysis requested for clinical trials and regulatory submissions. Analysis will include providing tables, line listings and multiple figures in accordance with protocols. As a member of the core team you will also participate in the review of study reports.

Qualifications:

Education:

• Master’s degree or higher in Statistics/Biostatistics minimally required.

• Certifications in SAS programming.

Experience:

• At least 2 years of experience in the responsibilities above preferred

• Experience and expertise in data analysis with in-vitro diagnostics, medical devices, pharmaceutical, or life sciences.

• Software experience includes the need for proficiency in programming (SAS and SAS Macros, R) and query of database systems (SQL).

• Experience with analysis of sophisticated data from multiple sources and confirmed understanding of CLSI standards is a plus.

Knowledge , Skills, Abilities:

• A confirmed understanding of theory, experimental design and clinical trial methodologies, linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations.

• Ability to work on multiple projects and programs independently and performing within project teams in a fast-paced environment

• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solutions to novel problems.

• Excellent communication skills (written and spoken) which include harmonizing with peers and distilling concepts into simpler terms are attributes which are highly valued.

• Ability to flex your work schedule to accommodate multiple time zones is required.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

EEO/reasonable accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards