Associate Director, Biostatistics - job 2 of 2

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes, and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources.

You will be responsible for:

• Leading and managing team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Managing assignments and priorities of team members.
• Ensuring accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
• Coordinating achievement of major statistical deliverables and milestones in collaboration with other functions.
• Leveraging standardization to maximize global data integration and interpretability.
• Providing statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.
• Providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.
• Applying innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)
• Keeping abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
• Monitoring project progress and ensuring proper resource allocation for successful project deliverables against goals and timelines.

You will need to have:

• A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience
• Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design
• regulatory requirements relating to clinical development of drugs and biologics
• BLA/NDA experience including eCTD submissions
• Working knowledge of major statistical software programs including SAS
• Knowledge of CDISC requirements for SDTM and ADaM
• Excellent verbal and written communication skills, and excellent inter-personal skills.
• The qualified applicant must also be flexible, well-organized, and possess the ability to work well under pressure.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• PhD in Statistics/Biostatistics preferred.

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Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.