Biostatistician II, Pharmacovigilance Focus- Fully remote!

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

What will you do in this role

The Biostatistician II will work under the guidance of a Biostatistical Team Lead to implement statistical analysis plans involving complex longitudinal registry data available in several autoimmune disease areas. This individual will help to prepare appropriate analytic summaries and context for reports and publications.

The CorEvitas Biostatistics team at Thermo Fisher Scientific is comprised of three key focus areas: query work pharmacovigilance and registry coordination.

With query work we design analyze and report on research projects i.e. queries with our clients to produce publications for the public domain (e.g. abstracts posters podium presentations manuscripts etc.)

For our pharmacovigilance work we design studies analyze data and develop reports to provide real-world evidence regarding drug safety. We partner with our pharma clients to conduct long-term post-authorization safety studies to support FDA EMA or other regulatory commitments.

Within our registry coordination team we work cross-functionally with the Engineering Clinical Data Management and Project Management teams on all registry data while incorporating client requests from the query and PV work.

A day in the Life of a Biostatistician II within this team:

Compiles analyzes and reports statistical data for various projects

Conducts complex statistical analyses with supervision in accordance with statistical analysis plans

Supports the Biostatistical Team Lead in developing new statistical methodologies for data analysis

Applies advanced statistical methods which may include simulation models and other statistical programming as needed

Reviews relevant literature and existing data assesses data quality and demonstrates increasing independence in statistical decision-making

Contributes to research projects and takes initiative in professional activities

Closely collaborates and participates in knowledge sharing with other statistical analysts

Utilizes various database management systems as required

Qualification requirements:

Education requirements

Masters degree in Biostatistics Statistics Bioinformatics Mathematics or related field is required.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Experience requirements

A minimum of 3 years of applied statistical experience is required.

Experience programming in R for data manipulation and statistical analysis is required.

Experience programming in SAS is required.

Experience equivalent to 3 years working with complex longitudinal datasets and applying advanced statistical methods is preferred.

Experience with causal inference theory and methods is a plus.

Knowledge Skills Abilities

Must be highly organized and detail-oriented with excellent time management skills and the ability to prioritize tasks

Must possess strong communication skills and be able to work independently and as part of a team

Requires clear writing skills and must follow best practices for commenting of programming code

Location: Remote from home in the US! This role does not offer relocation benefits.

*Must be legally authorized to work in the United States withoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes a drug screening.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of 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 reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.

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: Experience:

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