United States,
Posted: Jul 18, 2024
RemoteFull-time
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Skills Required
Biostatistics
expert
Clinical Research
expert
Biopharma
Proficient
FDA Submission
Proficient
Microsoft Office
Proficient
Statistical Analysis
Proficient
Regulatory Affairs
Proficient
Analytics
intermediate
Clinical Trial Study Protocols
intermediate
SAS
intermediate
Nice To Have skills
Job Description
McKesson requires new employees to be fully vaccinated for COVID-19 as defined by the CDC, subject to applicable, verified accommodation requests.

Transforming the fight against cancer!

Ontada is an oncology technology and insights business dedicated to transforming the fight against cancer. Part of McKesson Corporation, Ontada was founded on the core belief that precise insights – delivered exactly at the point of need – can save more patients’ lives. We connect the full patient journey by combining technologies used by The US Oncology Network and other community oncology providers with real-world data and research relied on by all top 15 global life sciences companies. Our work helps accelerate innovation and power the future of cancer care.

Position Summary
As the Director of Biostatistics within the Real World Research (RWR) team delivering to Life Sciences companies, you will provide direction and oversight on observational research proposals, protocols, statistical analysis plans, and analysis, review study reports and regulatory submission materials and ensure adherence to standard procedures. The Director will also lead, manage and provide mentorship to biostatisticians in the department and facilitate consistent statistical approaches across teams and locations. You will provide direct contributions as appropriate to complex statistical analysis plans and analysis approaches to gain alignment across the organization. The or Director builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to facilitate agile and robust research development plans and decision frameworks, working closely with a team of researchers, analysts, and statisticians to provide statistical expertise and input.

Key Responsibilities
  • Monitor and assess the progress status of ongoing real world observational research projects
  • Accountable for ensuring high quality standards, on time delivery within budget for all stages of the research – from protocol development, statistical analysis planning and execution, to the writing of statistical sections of the study reports or the generation of publications of research results
  • Oversee validation of statistical results generated by biostatisticians on statistical and programming deliverables before they are released to clients
  • Provide statistical consulting for programmatic statistical methods of analysis, protocols, and Statistical Analysis Plans (SAPs)
  • Facilitate implementation of innovative approaches and increase operational efficiency by close monitoring of the operating procedures and strategies for Biostatistics. Serve as primary oversight of biostatistics protocols, analysis plans, and study reports
  • Provide functional/technical guidance and support for all biostatisticians in assigned studies
  • Assist in the development of new statistical processes, tools and modeling protocols
  • Provide guidance and direct input in addressing statistical issues from regulatory, legal, or other challenges to the company's studies and represent the company in key regulatory meetings
  • Responsible for developing and implementing standard and repeatable processes and related KPIs in support of the function
  • Support business development activities by providing input on proposals and conducting feasibility studies
  • Assist with the management and provide mentorship to biostatisticians in the Real World Research department and facilitate consistent statistical approaches across teams and locations.
  • Build and lead a best-in-class team and facilitate its success in maintaining and improving the confidence of internal and external constituencies
  • Develop staff through coaching and training. Provide broader mentoring and guidance to ensure that the Biostatistics/RWR missions and goals are achieved. Collaborate with leaders in developing short and long-range business initiatives and goals
  • Develop relationships based on trust, confidence, and respect
  • Establish credibility across the organization for both Ontada and McKesson.
  • Articulate goals and objectives into specifics that are easily understood and hold people accountable for agreed-to results
  • Supervise the activities of biostatisticians with the goal of creating a highly collaborative work environment committed to outstanding performance and outcomes
  • Advise/work in close conjunction with PMO and project Research Lead(s) on delegation of biostatistician work, availability and assignments
  • Coaches, develops, and directs a team of professionals through empowerment and delegation to achieve peak performance and meet strategic objectives set forth by the business
  • Ensure high quality employee attraction, engagement, and development at all levels, building bench strength through modeling of ICARE/ILEAD and development of a high-performing culture
  • Resolve all statistical/technical issues and concerns and provide support and resources to research project teams, as applicable

Minimum Requirements
  • 12+ years of relevant biostatistics (real world observational research) and/or clinical research experience within a life science and/or biopharma capacity (2-3 less years required with a Ph.D.)
  • 4+ years of diversified leadership, planning, communication, organization, and people management
  • MS in Biostatistics with a Ph.D. strongly preferred
  • Critical Skills
  • Experience developing and leading high-performing research teams with multi-functional backgrounds
  • Strong quantitative analytical skills, business acumen and insight; with the ability to understand and synthesize data from various sources, work around data limitations, and form impactful judgments and insights
  • Broad and thorough understanding of statistical principles and clinical trial methodology with the ability to develop innovative/creative statistical/technical solutions to complete problems
  • Close collaboration across multiple disciplines with both internal and external partners, and must align tightly with executives, life science partners, researchers, data services, and other medical and operational services to promote an environment of superior quality and timeliness in deliverables.
  • Previous interaction with FDA submission is desired; experience in design and/or analysis of surveys a plus.
  • Strong leadership, interpersonal and exceptional communication skills with the ability to translate technical and non-technical content
  • Adept at managing expectations in internal and externally facing roles including through influencing and leading cross-functional teams
  • Ability to manage multiple priorities, projects and deadlines while maintaining a high degree of accuracy in outputs
  • Detailed knowledge of SAS programming and procedures and other statistical software Proficient with Microsoft Word, PowerPoint and Excel and Webex/Microsoft Teams

McKesson Total Rewards

Paid time off subject to eligibility, including paid parental leave, vacation, sick, and bereavement
Other benefits, subject to elections, eligibility, and collective bargaining agreement terms: Medical, Dental, Vision, Disability, Health and Dependent Care Reimbursement Accounts, Employee Assistance Program (EAP), Insurance (Accident, Group Legal, Life), 401k and Stock Purchase Programs

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to Disability_Accommodation@McKesson.com. Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.

Join us at McKesson!

Benefits found in job post
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • Disability insurance
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Additional Info
Min. Experience
-
Job Location Type
Remote
Job Type
Full-time
Predicted Seniority Level
-
Job Duration
Any
Language(s)
English
Est. Budget/Pay Rate
To be discussed
Est. hrs
-
Optimal Job Start
Urgent
Job Industry
-
Job Function
-
Employer
Ontada
Preferred Applicant Countries
United States
Job Ref
J22447F1FD85C
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