Principal Biostatistician (Medical Affairs Required)

Description

*Please submit all CVs in English

*Must be located in UK, Ireland, Hungary, Greece, Poland, Spain, South Africa, Romania, Ukraine, Mexico, Argentina, Brazil, or Columbia to be considered.

Principal Biostatistician (Medical Affairs)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

1. Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
2. Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
3. Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
4. Prepares or oversees the preparation of Statistical Analysis Plans (SAPs).
5. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
6. Implements company objectives, and creates alternative solutions to address business and operational challenges.
7. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
8. Provides statistical programming support as needed.
9. May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
10. Maintains well organized, complete, and up-to-date project documentation.

Qualifications
What we're looking for

1. Must have previous lead experience within a Medical Affairs Clinical Trial Setting.
2. Graduate degree in biostatistics or related discipline.
3. Extensive experience in clinical trials or an equivalent combination of education and experience.
4. Proficiency in programming.
5. Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques.
6. Excellent written and verbal communication skills.
7. Ability to read, write, speak, and understand English.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.