Job#: 3013804

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for an Biostatistician Manger. For applicants who are interested in this opportunity, send your updated resume to Mike Konjoian, Account Manager, at [email protected].

Here are the details:

Position: Biostatistician Manger

Location: Remote

Project Duration: 6 month contract with potential to extend

Rate: Negotiable Based on Experience

JOB DESCRIPTION

The newly created Biostatistician Manger role will report directly to the Senior Manager, Global Clinical Affairs Data. This position will play a critical role in leading the team and providing expert statistical support for internally sponsored, real-world evidence (RWE), and external clinical studies. The position requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry. The position requires strong leadership skills, the ability to navigate complex analyses, and proficiency in statistical software.

The Biostatistician Manager will collaborate closely with cross-functional teams to ensure the successful development and approval of medical devices. In addition, this role will demonstrate strong communication/presentation skills and will support senior leaders in data analytics.

Responsibilities:

· Lead and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians.

· Develop and implement statistical methodologies for sample size calculations and power analysis.

· Generation of randomization schedules.

· Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies.

· Manage various datasets, determine summary statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations.

· Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs.

· Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures

· Review and provide input to study protocols, and clinical study reports.

· Collaborate with cross-functional teams, including Regulatory Affairs, R&D, ADO, and Marketing, to ensure robust statistical support for product validation and claims.

· Ensure compliance with regulatory requirements and industry standards for statistical practices.

· Present findings and statistical insights to stakeholders, including senior management and regulatory bodies and effectively communicate statistical concepts.

· Stay updated with the latest advancements in biostatistics and medical device regulations.

· Deliver special projects / ad-hoc reporting as needed.

· Develop and maintain internal SOPs to establish formal procedures ensuring the quality of statistical aspects of studies

Education and Experience:

· Master's or Ph.D. in Biostatistics, or Statistics.

· Minimum of 6+ years of experience in biostatistics within the medical device industry.

· Proven experience in navigating complex statistical analyses and sample size calculations.

· Strong knowledge of clinical trial design and regulatory requirements.

· Strong knowledge of statistical methodologies, experimental design, and analytical and problem-solving abilities.

· Effective communication skills, both written and verbal.

· Ability to work collaboratively in a fast-paced, multidisciplinary environment.

Skills/Competencies:

· Proficiency in statistical software, including SAS, R, SPSS, and other relevant tools.

· Excellent leadership and team management skills with the ability to multi-task.

· Diabetes experience a plus.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.