Senior Biostatistics Manager, RWE Clinical Trials - Remote

Job Summary
The Senior Manager Biostatistics will generate Clinical Trial and Real World Evidence (RWE) from various study designs as well as Walgreen's database of 100 plus million patients. As part of the overall Clinical Trials Data Science team, this role will develop innovative and scalable analytical processes, lead statistical analyses, and conduct ad-hoc analyses that reflects and advances health care for a diverse patient population. Our customers are biopharmaceutical, medical device and digital therapeutic companies focused on generating evidence that support regulatory decision making and value propositions for market access expansion. This role supports RWE and clinical trial study delivery, working cross functionally with members of the Clinical Trial Solutions delivery team, data engineering, product management, and sponsor teams.

Job Responsibility

• Develop and drive innovative and efficient study design for study objectives that support medical research, market access, and regulatory approval.
• Independently lead, initiate, conduct, or oversee statistical support for RWE and trial requirements of biopharmaceutical sponsor programs.
• Present and defend statistical solutions to key stakeholders in a clear, concise, complete, and transparent manner that provide influence on key decisions.
• Provide statistical support to address health authority requests, publications, presentations, and other public release of information.
• Manages project execution, identifies and activates resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.
• Stay abreast of HEOR RWE methods and applications.
• Provide active coaching to data science team members on RWE methods.
• Contribute to creation/maintenance of and provide training on statistical topics as well as relevant SOPs.
• Enable a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.
• Function as subject matter expert on HEOR and RWE, including sharing knowledge and recommendations to other functions.
• Develop strong cross functional relationships with other RWE and Clinical Trial teams.

"About Walgreens and WBA
Walgreens (www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader with a 170-year heritage of caring for communities. WBA's purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nation's medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in communities nationwide."
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits.
"An Equal Opportunity Employer, including disability/veterans".

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Basic Qualifications

• Masters in statistics or biostatistics or related scientific field with RWE/HEOR, clinical trials, drug development or pharmaceutical industry experience
• At least 4 years in consulting, CRO, or pharmaceutical industry with evidence of solid career progression
• Experienced in RWE study execution work, including authoring SAP and TFL specifications.
• High proficiency in analytical computing applications (R, Python, or SAS) and conduct of advanced statistical analysis, modeling, simulation, and visualization.
• High proficiency in SQL and relational database systems (on prem or cloud).
• Demonstrate excellent collaboration, organizational/ leadership, communication, and interpersonal skills.
• Experience in collaborating with sponsors' US Payer, Market Access, Pharmacoepidemiology or Medical Liaison teams to meet evidentiary requirements.
• At least 2 years of experience contributing to financial decisions in the workplace.
• At least 2 years of direct leadership, indirect leadership and/or cross-functional team leadership.
• Willing to travel up to/at least (10 percent) of the time for business purposes (within state and out of state).

Preferred Qualifications

• At least 4 years experience with claims data or electronic health records and corresponding data standards
• Experience working in a health care technology or analytics firm is a plus
• Experience in preparing and participating in global regulatory agency interactions through knowledge of FDA, EMA and ICH regulations and guidelines is a plus
• Knowledge in CDISC requirements, including SDTM and ADaM is a plus