Director, Statistics

Teva Pharmaceutical Industries Malvern , PA 19355

Posted 2 months ago

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description


The Director, Statistics position is for a skilled statistician with training and significant experience in drug development and clinical research. He or she is expected to provide statistical leadership for overall program and individual study strategy for multiple therapeutic areas within clinical research and development from phases 1-4. He or she needs to be an expert in statistical principles and appropriate software and tools to perform his or her tasks. A Director, Statistics must be a strong individual contributor and a dynamic leader within the organization possessing creative and strategic thinking and knowledge of cutting-edge complex, innovative clinical trial design and methodology for all phases of clinical development. He or she must have experience with regulatory submissions both in the US and outside of the US. He or she must have excellent written and oral communication skills and must be willing to lead and mentor clinical statisticians within their team. This position will be located in Frazer, PA or Netanya, IL.

Responsibilities include but are not limited to:

Providing strategic and scientific leadership to the entire clinical development process, registration strategy, submission, health authority interactions, and medical affairs/market access plans for complex programs across therapeutic areas. He/she must be an organizational leader that is a key contributor in defining and driving the line function strategy.

The Director will lead and optimize the contribution from the team(s) by collaborating and consulting with Research/Development/Medical Affairs/Market Access partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills. They are a key contributor to the decision making governance for Teva.

  • Strategic and/or managerial responsibilities for Biostatistics across multiple programs/ indications of Teva. Lead (large) therapeutic areas and accountable for the statistical input and influence for the programs for themselves and their direct reports (Clinical Development Plan: CDP, dose-finding, regulatory strategy, publication, pricing/market access).

  • A modern drug development global leader operate as a full partner to clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory and other strategic functions to drive quantitative decision sciences / making in drug development and enable successful impact on CDPs, programs and trials.

  • Interact and manage KOLs/CROs and represents the company in external scientific and industry forums.

  • Is seen as a strategic Business partner involved in high-level decisions having an impact on the organization globally.

  • Leading clinical development and global statistics through the use of novel/innovative clinical trial designs and statistical methodology

  • Becomes proficient in the knowledge of the therapeutic area and competitive landscape of the specified therapeutic areas

  • Provides consultation on clinical endpoint assessments and sample size planning for clinical studies

  • Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with Clinical Research personnel.

  • Writes, or oversees the writing of, statistical analysis plans

  • Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of CNS products


  • Ph.D. in Statistics/Biostatistics (or related field) with a minimum of 10 years of related experience

  • Excellent presentation and written communications skills.

  • Expert in the planning, analysis and reporting of clinical trials with a strong knowledge of complex, innovative trials

  • Ability to communicate with non-statisticians to interpret statistical findings

  • Good organizational and problem-solving skills.

  • Demonstrated project and technical leadership qualities, and creative and strategic thinking required.

  • Excited and willing to manage and mentor statisticians within a team

  • Ability to program using SAS, knowledge of R is beneficial

  • Knowledge of CDISC SDTM and ADaM

  • Knowledge of relevant FDA and CHMP guidelines

  • Experience with regulatory submissions in the US

  • Experience with regulatory submissions outside the US

  • Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications is preferred.

  • Provides thought leading perspective into the external/ competitive environment and internal partner interface.


Research & Development

Sub Function


Reports To

Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Nearest Major Market: Philadelphia

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Director

Malvern Institute

Posted 2 days ago

VIEW JOBS 11/18/2018 12:00:00 AM 2019-02-16T00:00 Promotes the safety/wellness and well-being of patients. Enforces and develops policies and procedures to provide for the safety of patients and staff. Develops both weekday and weekend programs in concert with evidence-based practices. Provides one-on-one supervision to clinicians and engages in both individual and group supervision with counselors. Participates actively in morning meetings, change-of-shift meetings and daily case conference meetings, providing information and support in concert with the Executive Director and Clinical Supervisor(s). Provides orientation of new counseling staff to include basic counseling techniques, group dynamics, medical records documentation and treatment plan assessments. Emphasizes the importance of interactions with families and referral sources. Ensures appropriate documentation by counselors. Documents significant individual, family and group interactions. Participates actively in utilization management functions to ensure appropriate authorizations for care; is well-versed in admission, concurrent and discharge criteria as outlined by the American Society of Addiction Medicine. Recruits, interviews and assists in the selection of new counseling staff. Evaluates all staff to ensure department and program licensing and accreditation standards are consistently met. Provides ongoing trainings to assist in counselors' professional growth. Ensures that staffing for the counseling operations meets but does not exceed staffing schedules as outlined in position control. Works actively to reduce overtime through appropriate staffing. Develops and implements new clinical programs according to patient needs, including active participation in development of daily therapeutic schedule, evaluation of program and making suggestions for changes and assist in licensure/certification standards and compliance. Delivers lectures and staff workshops and facilitates task groups. Substitutes for counselors, but assuming responsibility for caseloads as directed by the Executive Director. Participates actively in regular meetings, including but not limited to, Operations and Quality Management. Acts as a member of treatment team including facilitating group therapy, individual therapy, lectures and workshops. Creates liaison with community resources as part of a network for continuum of care and provides community education and outreach programs. Intervenes in therapeutic process with patients who need special attention. Maintains all required documentation and must complete 12 hours of training per year. Remains willing to assist in case management when census indicates. Communicates actively with Malvern Outpatient Programs, emphasizing the Malvern 90-day Model of Care. Ensures coverage in absence of counselor(s). Other functions as assigned. Supervisory Responsibilities: Performance management for the Clinical staff. Qualifications: An individual must be able to perform each essential duty satisfactorily. This position requires individuals that are client focused; team oriented; great interpersonal and communication skills; flexible to sudden changes in workload, emergency or staffing; dependable; problem solving skills; focused on compliance and performance quality. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: A Master's Degree, Bachelor's Degree or Associate's Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field which and two years of clinical experience in a health or human service agency which includes one year of working directly with the chemically dependent, or Full certification as an addictions counselor & three years of clinical experience in a health or human service agency, which includes one year of working directly with the chemically dependent. Individual shall also complete a Department approved core curriculum training which includes a component on clinical supervision skills. Technical/Computer Skills: Microsoft Office Proficient. Knowledge of addiction and basic management principles. Emergency Classification: Non-Essential Personnel Work Environment and Hazards: No hazardous conditions. Protected from weather conditions. Physical Requirements: Sedentary work – lifting 10lbs maximum. Travel Required: No RESPONSIBILITIES * Gets involved in projects that improve delivery of treatment and participates in ongoing educational and training process * Interacts with co-workers in a helpful manner that contributes to high morale * Performs evaluations for potential admissions and refers patients to appropriate level of care based on ASAM criteria * Performs other duties as assigned * Provides one-on-one clinical supervision to staff * Assists in recruitment of new counseling staff * Communicates actively with Malvern Outpatient Programs, emphasizing the Malvern 90-day Model of Care. * Acts as a member of treatment team including facilitating group therapy, individual therapy, lectures and workshops. QUALIFICATIONS * Master's degree in a related field preferred; will accept Bachelor's or Associate's degree with corresponding experience * One to two years of clinical experience in a health or human service agency, preferably in a drug and alcohol setting * Knowledge of 12-step recovery and an understanding of chemical dependency * Able to provide individual counseling as well as group therapy * Able to work in a supportive, caring, and non-judgmental manner with staff and patients in order to gain confidence and cooperation * Able to operate as a role model in speech and behaviors consistent with recovery principles * Confident, articulate, and able to speak effectively in front of groups and individuals to provide education/training * Demonstrated proficiency at educating, communicating, and empathizing with patients, answering questions and concerns in a manner that is respectful BENEFITS * Health Insurance * Dental Insurance * Life Insurance * Paid Time Off (PTO) * Holiday Pay * 401(K) * Long-term Disability Insurance * Bereavement Leave Malvern Institute Malvern PA

Director, Statistics

Teva Pharmaceutical Industries