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Sheikh@innovasolutions.com
IS
Innova Solutions
Associate Director, Biostatistics
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What they do
A Biostatistics Manager or Director manages a team of statisticians and directs statistical analysis and reporting of health and biology-related data. Analysis may be used for product development at a pharmaceutical company, disease research at a hospital or health policy research at a public health organization. Directs the design of statistical analysis and reviews analysis and findings; may manage regulatory reporting for projects such as clinical trials.
$183,222 / year median in the U.S.
Job Description
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Innova Referral Bonus $250-$1,000 Referral Bonus Terms & Conditions Refer a friend Refer this job to a friend Associate Director, Biostatistics Enter your information Enter your information below First name- Last name
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- Last name
- Email address
- Phone number
- United States +1 United Kingdom +44 Afghanistan (افغانستان) +93 Albania (Shqipëri) +355 Algeria (الجزائر) +213 American Samoa +1 Andorra +376 Angola +244 Anguilla +1 Antigua and Barbuda +1 Argentina +54 Armenia (Հայաստան) +374 Aruba +297 Australia +61 Austria (Österreich) +43 Azerbaijan (Azərbaycan) +994 Bahamas +1 Bahrain (البحرين) +973 Bangladesh (বাংলাদেশ) +880 Barbados +1 Belarus (Беларусь) +375 Belgium (België) +32 Belize +501 Benin (Bénin) +229 Bermuda +1 Bhutan (འབྲུག) +975 Bolivia +591 Bosnia and Herzegovina (Босна и Херцеговина) +387 Botswana +267 Brazil (Brasil) +55 British Indian Ocean Territory +246 British Virgin Islands +1 Brunei +673 Bulgaria (България) +359 Burkina Faso +226 Burundi (Uburundi) +257 Cambodia (កម្ពុជា) +855 Cameroon (Cameroun) +237 Canada +1 Cape Verde (Kabu Verdi) +238 Caribbean Netherlands +599 Cayman Islands +1 Central African Republic (République centrafricaine) +236 Chad (Tchad) +235 Chile +56 China (中国) +86 Christmas Island +61 Cocos (Keeling) Islands +61 Colombia +57 Comoros (جزر القمر) +269 Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) +243 Congo (Republic) (Congo-Brazzaville) +242 Cook Islands +682 Costa Rica +506 Côte d'Ivoire +225 Croatia (Hrvatska) +385 Cuba +53 Curaçao +599 Cyprus (Κύπρος) +357 Czech Republic (Česká republika) +420 Denmark (Danmark) +45 Djibouti +253 Dominica +1 Dominican Republic (República Dominicana) +1 Ecuador +593 Egypt (مصر) +20 El Salvador +503 Equatorial Guinea (Guinea Ecuatorial) +240 Eritrea +291 Estonia (Eesti) +372 Ethiopia +251 Falkland Islands (Islas Malvinas) +500 Faroe Islands (Føroyar) +298 Fiji +679 Finland (Suomi) +358 France +33 French Guiana (Guyane française) +594 French Polynesia (Polynésie française) +689 Gabon +241 Gambia +220 Georgia (საქართველო) +995 Germany (Deutschland) +49 Ghana (Gaana) +233 Gibraltar +350 Greece (Ελλάδα) +30 Greenland (Kalaallit Nunaat) +299 Grenada +1 Guadeloupe +590 Guam +1 Guatemala +502 Guernsey +44 Guinea (Guinée) +224 Guinea-Bissau (Guiné Bissau) +245 Guyana +592 Haiti +509 Honduras +504 Hong Kong (香港) +852 Hungary (Magyarország) +36 Iceland (Ísland) +354 India (भारत) +91 Indonesia +62 Iran (ایران) +98 Iraq (العراق) +964 Ireland +353 Isle of Man +44 Israel (ישראל) +972 Italy (Italia) +39 Jamaica +1 Japan (日本) +81 Jersey +44 Jordan (الأردن) +962 Kazakhstan (Казахстан) +7 Kenya +254 Kiribati +686 Kosovo +383 Kuwait (الكويت) +965 Kyrgyzstan (Кыргызстан) +996 Laos (ລາວ) +856 Latvia (Latvija) +371 Lebanon (لبنان) +961 Lesotho +266 Liberia +231 Libya (ليبيا) +218 Liechtenstein +423 Lithuania (Lietuva) +370 Luxembourg +352 Macau (澳門) +853 Macedonia (FYROM) (Македонија) +389 Madagascar (Madagasikara) +261 Malawi +265 Malaysia +60 Maldives +960 Mali +223 Malta +356 Marshall Islands +692 Martinique +596 Mauritania (موريتانيا) +222 Mauritius (Moris) +230 Mayotte +262 Mexico (México) +52 Micronesia +691 Moldova (Republica Moldova) +373 Monaco +377 Mongolia (Монгол) +976 Montenegro (Crna Gora) +382 Montserrat +1 Morocco (المغرب) +212 Mozambique (Moçambique) +258 Myanmar (Burma) (မြန်မာ) +95 Namibia (Namibië) +264 Nauru +674 Nepal (नेपाल) +977 Netherlands (Nederland) +31 New Caledonia (Nouvelle-Calédonie) +687 New Zealand +64 Nicaragua +505 Niger (Nijar) +227 Nigeria +234 Niue +683 Norfolk Island +672 North Korea (조선 민주주의 인민 공화국) +850 Northern Mariana Islands +1 Norway (Norge) +47 Oman (عُمان) +968 Pakistan (پاکستان) +92 Palau +680 Palestine (فلسطين) +970 Panama (Panamá) +507 Papua New Guinea +675 Paraguay +595 Peru (Perú) +51 Philippines +63 Poland (Polska) +48 Portugal +351 Puerto Rico +1 Qatar (قطر) +974 Réunion (La Réunion) +262 Romania (România) +40 Russia (Россия) +7 Rwanda +250 Saint Barthélemy +590 Saint Helena +290 Saint Kitts and Nevis +1 Saint Lucia +1 Saint Martin (Saint-Martin (partie française)) +590 Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) +508 Saint Vincent and the Grenadines +1 Samoa +685 San Marino +378 São Tomé and Príncipe (São Tomé e Príncipe) +239 Saudi Arabia (المملكة العربية السعودية) +966 Senegal (Sénégal) +221 Serbia (Србија) +381 Seychelles +248 Sierra Leone +232 Singapore +65 Sint Maarten +1 Slovakia (Slovensko) +421 Slovenia (Slovenija) +386 Solomon Islands +677 Somalia (Soomaaliya) +252 South Africa +27 South Korea (대한민국) +82 South Sudan (جنوب السودان) +211 Spain (España) +34 Sri Lanka (ශ්රී ලංකාව) +94 Sudan (السودان) +249 Suriname +597 Svalbard and Jan Mayen +47 Swaziland +268 Sweden (Sverige) +46 Switzerland (Schweiz) +41 Syria (سوريا) +963 Taiwan (台灣) +886 Tajikistan +992 Tanzania +255 Thailand (ไทย) +66 Timor-Leste +670 Togo +228 Tokelau +690 Tonga +676 Trinidad and Tobago +1 Tunisia (تونس) +216 Turkey (Türkiye) +90 Turkmenistan +993 Turks and Caicos Islands +1 Tuvalu +688 U.
Position type:
Full-time- Contract Duration:
3+Months Location:
REMOTE As Associate Director, Biostatistics, you will:Job Description:
The Associate Director of Biostatistics acts as indication/study statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance.Responsibilities:
1. Lead in indication/study level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective 2. Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings 3. Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements 4. Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results 5. Contribute to developing standards and research in advanced statistical methodologies 6. Author/review regulatory documents or scientific publicationsRequirements:
1. PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry 2. Experienced inNDA / BLA / MAA
activities as a key contributor from statistics perspective and direct involvement in regulatory interaction 3. Experienced as study lead statistician and contributing to strategy discussion in cross functional settings 4. Experienced in study level work including authoring SAP and TFL specification 5. Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance 6. Solid understanding of mathematical and statistical principles 7. Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies. Qualified candidates shouldAPPLY NOW
for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines.ASK ME HOW.
Thank you!Lailun Sheikh Phone:
412-763-1477 Lailun.Sheikh@innovasolutions.com
PAY RANGE AND BENEFITS
Pay Range- : $75.00-$90.00 per hour.
- Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.