Senior Manager, Biostatistics Position Available In Suffolk, Massachusetts

Job Description:

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Job Description About the role:

TheBiostatistics, Senior Manager is responsible for providingstatistical support for early and late phase clinical trials in theOncology Therapeutic Area statistics group and timely delivery ofstatistical deliverables. This role contributes to Takeda’smission.

How you will contribute:

Design clinical trials, providestrategic inputs and innovative solutions, and support the team tomake data-driven quantitative decisions Conduct advancedstatistical analysis and ensure robust and accurate data analysisthrough extensive knowledge in biostatistics Support the adoptionof novel designs and innovative statistical methods Facilitateexecution and delivery collaboration with cross-functional teams toachieve project objectives Lead and be accountable for study leveldelivery strategies being implemented with effective riskidentification and mitigation Skills and qualifications: Knowledgeof drug development, clinical study design, trial simulations,analysis methodology and data interpretation. Innovative thinker,driving the adoption of novel design, innovative statisticalmethods and complex modeling. Knowledge of FDA and ICH regulationsand industry standards applicable to study design, data analysis ofclinical trials and regulatory submissions. Statistical leadershipand support for quantitative decision making, regulatory meetings,and submissions. Strong collaborative skills and ability toeffectively work with a cross-functional team to achieve projectobjectives. Strong statistical programming skills (SAS and/or R).Excellent oral and written communications skills. Specializedstatistical expertise in multiple therapeutic areas or clinicaltrial development phases. (Experience in Oncology preferred.)Strong inter-personal skills. Strong project management and timemanagement skills. As a recognized expert within your business orfunction, you possess comprehensive expertise in your disciplineand broad knowledge across related areas. You excel at anticipatinginternal/external challenges, recommending improvements, andproviding leadership and consultative expertise for a specificbusiness, region or function. Your role involves shaping companypolicies, solving unique, far-reaching problems affectingoperations, disciplines, or other business units/functionalareas/regions. You frequently interact with equivalent-levelmanagers and customer representatives, conducting briefings andtechnical meetings. Operating independently, you provide guidancein the complex situations, lead functional teams or projects, andserve as a best practice/quality resource.

OBJECTIVES/PURPOSE

Takeda is a global, values-based, R D-driven, top 10biopharmaceutical leader committed to discover and deliverlife-transforming treatments, guided by our commitment to patients,our people and the planet. Our Data and Quantitative Sciences (DQS)is made up of more than 250 quantitative scientists who harness theinsight of data and digital to speed the development of highlyinnovative treatments to patients. These scientists (fromstatistics, programming, outcomes research and epidemiology, andquantitative clinical pharmacology,) bring their expertise to ourglobal program teams and re-imagine our disciplines. Theywork withnovel data streams, including real-world data and digital tools,and apply advanced analytics including artificial intelligence andautomation. As part of DQS, the Statistics and QuantitativeSciences (SQS) at Takeda is looking to add individuals to our teamthat are team oriented, collaborative, strong understanding of thestatistics function, exceptional leaders and innovators. SQSaspires to bring safe and effective medications to the patientswith our quantitative skills. We design efficient trials,contribute to clinical development strategies, perform high qualitystatistical analyses, and pursue operational excellence.

Delivery &Business Accountabilities:

A Senior Manager in Statistics isexpected to: Lead delivery for one or more assets at study levelFacilitate execution and delivery collaboration cross functionally,generally within DQS and R D, and with external vendors Enablethe consistent execution of the SQS and DQS seamless andpredictable delivery mission Lead and be accountable for studylevel delivery strategies being implemented with effective riskidentification and mitigation Create an internal cross functionaland external with vendors sphere of influence in predictabledelivery Identify opportunity for continuous improvement indelivery approaches and leverages fit-for-purpose mitigations TheSenior Manager in Statistics, through her/his daily work, shouldhave impact on: Asset-level GPT strategy and delivery Broadly DQSfunctions Parts R D functions.

CORE ELEMENTS RELATED TO THISROLE

Knowledge of drug development, clinical study design,analysis methodology and data interpretation. Knowledge ofpharmaceutical industry, overall drug development process withexpertise in the cross-functional interfaces with the Statisticsfunction. Knowledge of FDA and ICH regulations and industrystandards applicable to the design, analysis of clinical trials andregulatory submissions. Provide statistical support for internaldecision making, regulatory meetings, submissions and follow up.

Collaborate/lead in the development of study-level sourcing/vendorstrategies and provide oversight of statistical services, ensuringoverall quality. Strong statistical programming skills (SAS and/orR) Excellent oral and written communications skills. Specializedstatistical expertise in multiple therapeutic areas or clinicaltrial development phases. Strong inter-personal skills. Strongproject management and time management skills. Strong collaborativeskills and ability to work with a cross-functional team. ?Technical/Functional (Line)

Expertise:

The Senior Manager inStatistics needs to demonstrate: Subject matter expertise inseveral quantitative and statistical areas and establishes oneselfas a go-to colleague on a few topics Scientific understanding ofdrug development to inform methodological input with product teamor in a platform Strong communication skills and ability totranslate effectively across functional lines Ability to identifyand research new innovative approaches and leverage fit-for-purposemethods into programs that he/she is involved in

Leadership:

As aStatistician, the Senior Manager may have to: Lead one or morestudies Facilitate collaboration cross functionally and generallywithin DQS and R D Enable the tactical execution of the SQS andDQS vision and mission Lead and be accountable for study levelstrategies being implemented

EDUCATION

Applicant for this positionshould have degree in statistics/biostatistics or in otherequivalent quantitative sciences along with the following specificcredentials: PHD with ~ 3 years experience MS with ~ 6 yearsexperience

BEHAVIOURAL COMPETENCIES

An ideal candidate for thisposition should: Inspire teamwork Assess benefit risk of optionsDevelop understanding of business beyond SQS Focuses on prioritiesTakeda Compensation and Benefits Summary We understand compensationis an important factor as you consider the next step in yourcareer. We are committed to equitable pay for all employees, and westrive to be more transparent with our pay practices.

For Location:

Boston, MA U.S.

Base Salary Range:

$137,000.00 – $215,270.00 Theestimated salary range reflects an anticipated range for thisposition. The actual base salary offered may depend on a variety offactors, including the qualifications of the individual applicantfor the position, years of relevant experience, specific and uniqueskills, level of education attained, certifications or otherprofessional licenses held, and the location in which the applicantlives and/or from which they will be performing the job.

The actualbase salary offered will be in accordance with state or localminimum wage requirements for the job location. U.S. basedemployees may be eligible for short-term and/orlong-termincentives. U.S.based employees may be eligible toparticipate in medical, dental, vision insurance, a 401(k) plan andcompany match, short-term and long-term disability coverage, basiclife insurance, a tuition reimbursement program, paid volunteertime off, company holidays, and well-being benefits, among others.

U.S.based employees are also eligible to receive, per calendaryear, up to 80 hours of sick time, and new hires are eligible toaccrue up to 120 hours of paid vacation. EEO Statement Takeda isproud in its commitment to creating a diverse workforce andproviding equal employment opportunities to all employees andapplicants for employment without regard to race, color, religion,sex, sexual orientation, gender identity, gender expression,parental status, national origin, age, disability, citizenshipstatus, genetic information or characteristics, marital status,status as a Vietnam era veteran, special disabled veteran, or otherprotected veteran in accordance with applicable federal, state andlocal laws, and any other characteristic protected by law.

Locations Boston, MA Worker Type Employee Worker Sub-Type RegularTime Type Full time Job Exempt Yes It is unlawful in Massachusettsto require or administer a lie detector test as a condition ofemployment or continued employment. An employer who violates thislaw shall be subject to criminal penalties and civil liability.